2,137 Clinical Supply jobs in India
Clinical Supply Coordinator
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The Clinical Supply Coordinator provides support to the Clinical Trial Supplies team to support the on-time delivery of supplies (Investigational Medicinal Products and Non-Investigational Medicinal Products) to clinical sites for established clinical trials contracted to IQVIA. This is achieved through supporting the Associate Clinical Supply Chain Manager or Clinical Supply Chain Manager with effective inventory monitoring, ongoing forecasting of drug demand, initiation and delivery of packaging campaigns and a strong distribution strategy. The Clinical Supply Coordinator will ensure quality compliance, file documentation according to regulatory requirements, manage some finance aspects and general coordination of meetings, communications, tracking and inbox monitoring.
Essential Functions
- Ability to work independently and proactively to ensure that the supply of all trial materials is delivered to the right place at the right time
- Support maintenance of demand forecasts and packaging plans so that packed clinical supplies are readily available in accordance with the project requirements
- Assist in planning and paperwork for packaging campaigns with the assigned vendor and provide support to ensure on-time delivery
- Manage vendor Work Order, Change Order and Purchase Order progression upon Clinical Supply Chain Manager approval to move forward with quote
- Monitor, and where necessary, update study assigned Interactive Response Technology (IRT) systems to ensure study inventory is effectively managed
- Support the Clinical Supply Chain Manager with the execution of a clinical supply plan
- Provide ongoing budget tracking activities so that projects are run efficiently and in accordance with client approved quotations
- Provides administration support to the Clinical Trial Supplies team where required
- Participate in client and vendor related meetings where necessary to discuss Clinical Supply Chain topics or status updates
- Remain up to date in all GxP and regulatory requirements applicable to the role
- Maintains 100% compliance on all assigned training and applies learnings to everyday practice
- SOP, Project Instruction, Work Instruction creation and updates
- Monitor shared mailboxes
- Second person verification checks for specified processes
- Manage communications between vendor and IQVIA where applicable including capture of meeting minutes etc.
- Provides administration to support Clinical Supply Chain Manager with Temperature Excursions reported to the IQVIA Clinical Trial Supplies team
Qualifications
- High School Diploma or equivalent
- Typically requires 1 - 3 years of prior relevant experience.
1-3 Years related industry experience in Clinical Trials or Pharmacy (Preferred not essential).
1-3 Years related experience in Clinical Supplies - this could be from Supply Chain, Packaging, Distribution
or IRT functions (Preferred not essential).
- Proficient in Microsoft Office (Word, Excel, Powerpoint etc.)
Process Architect Clinical Supply Chain Planning - Clinical Supply Chain Support Systems
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Working with Us
Challenging. Meaningful. Life-changing. Those aren&apost words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You&aposll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us .
Job Description Process Architect Clinical Supply Chain Planning (EG 100) - Clinical Supply Chain Systems (CASSA) and Custom-built Robotic Process Automation (RPA&aposs)
Working With Us
Challenging. Meaningful. Life-changing. Those aren&apost words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You&aposll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more careers.bms.com/working-with-us
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients&apos lives through science. In oncology, hematology, immunology, and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Position Summary
At BMS, digital innovation and Information Technology are central to our vision of transforming patients&apos lives through science. To accelerate our ability to serve patients around the world, we must unleash the power of technology." We are committed to being at the forefront of transforming the way medicine is made and delivered by harnessing the power of computer and data science, artificial intelligence, and other technologies to promote scientific discovery, faster decision making, and enhanced patient care." "
Bristol Myers Squibb is advancing new and next-generation therapies while exploring and investing in technologies to optimize the planning processes to meet future needs. This role will serve as the delivery lead for Supply Planning and help in driving optimized solutions in the planning space while ensuring SLA compliant system support.
If you want an exciting and rewarding career that is meaningful, consider joining our diverse team!
Key Responsibilities
Support global process owners - and potentially business directly at times - in development of business/user requirements for new capabilities, enhancements, system upgrade for CASSA (Compound And Study Supply Analytics) and application-specific RPA&aposs. Serve as a clinical supply chain planning process expert translating business and user requirements into design changes of CASSA and RPA&aposs for IT partners. Support software engineers in seamless delivery of system solutions following best practices and aligning People, Process, Technology & Data. Engage with IT, Clinical Supply Chain and Business Insights & Technology (BI&T) colleagues in exploring cost-effective and sustainable technology solutions. Actively participate in various meetings with internal and external stakeholders in driving timely closure of projects and support activities. Manage portfolio of outstanding tickets (bug-fixes, enhancements), ensuring timely resolution as per the SLA guidelines, in partnership with B&IT. Support B&IT partners on unit and integration tests and assist with user acceptance testing. Provide system training on new capabilities to business leads.
Qualifications And Experience
1-3 years of experience in RPA technology as an analyst, consultant or end user. Intermediate to advanced understanding of analytics used in clinical supply chain forecasting & planning business processes. Experience with implementing or supporting deployments for custom-built tools. Bachelor&aposs Degree in engineering, supply chain, science field or related discipline is required. Agile and critical thinker with a passion for innovation and learning new skills. Excellent verbal, written and interpersonal communication skills; ability to strategically collaborate and influence in the defined area of scope. Ability to easily navigate and prioritize through multiple tasks and initiatives. Ability to balance strategic awareness & direction setting with consistent tactical results. Good planning, problem solving, analytical, time management and organizational skills.
If you come across a role that intrigues you but doesn&apost perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients&apos lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to (HIDDEN TEXT) . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information https //careers.bms.com/california-residents/
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Skills Required
CASSA, custom-built tools, RPA technology
Strategic Clinical Supply Manager
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Job Title: Supply Chain Strategist
As a key member of our team, you will be responsible for developing and executing a comprehensive supply chain strategy that meets the needs of our clinical trials.
Key Responsibilities:- Supply Chain Strategy Development: Define and implement an optimal supply chain strategy for clinical trials, taking into account packaging design, technical feasibility, efficiency, and risk management.
- Clinical Trial Protocol Review: Review overall clinical trial protocols and provide input on optimal packaging design, clinical supply design, and visit schedules.
- Supply Demand Forecasting: Create and maintain accurate clinical supply demand forecasts for assigned studies, aligned with protocol requirements and milestones.
- Packaging Design and Label Strategy: Develop and finalize packaging designs and label strategies for all participating countries in the clinical trial.
- Clinical Supply Parameters: Define clinical supply parameters for NIRT setup and initiate subsequent updates throughout the clinical trial.
- Trial-Level Project Planning: Develop and execute trial-level project plans with relevant stakeholders.
- Supply Risk Management: Identify, assess, and proactively communicate supply risks to stakeholders, along with mitigation strategies to ensure supply continuity.
- Education: Master's or Doctorate in life sciences (or MBA with bachelor's degree) or equivalent experience in life sciences.
- Languages: Fluent in English.
- Experience: > 5 years of practical experience in clinical supplies within the pharmaceutical industry.
- Skills: Advanced project management, organization, and planning skills; broad technical knowledge in supply chain systems; data and digital savviness; knowledge of relevant regulations and Novartis specific standards.
We are a leading pharmaceutical company committed to improving patient outcomes through innovative products and services.
Why Join Us?
- Opportunity to Work on Complex Projects: As a Supply Chain Strategist, you will have the opportunity to work on complex projects that impact the success of our clinical trials.
- Collaborative Team Environment: You will be part of a collaborative team environment that values open communication, creativity, and innovation.
- Professional Growth and Development: We offer opportunities for professional growth and development, including training programs, mentorship, and career advancement.
Associate Clinical Supply Services
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Job Description
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.
**Associate Clinical Trial Supply**
Clinical Trial Supply is a global team of Clinical trial Supply Managers and Coordinators with offices in Germany, Japan and China. This year we are going to futher diversify our way of working adding a team of Clinical Trial Supply Associates located in India.
In the role of a Clinical Trial Supply Associate, you will be responsible for supporting the global Clinical Trial Supply team in the execution of clinical trial supply chain activities e.g., ensuring GxP compliant documentation for the certification of investigational medicinal products by a qualified person or in preparation for inspections by authorities.
**Responsibilities**:
- Support the coordination and management of clinical supply projects, including planning, scheduling, budgeting, and resource allocation.
- Archiving of clinical supply documentation in internal and external GMP and GCP systems ensuring clinical supply documentation meets GxP standards for inspection purposes.
- Organize and control the compilation of documents for approval by the competent person.
- Check (content and completeness) and archive technical specifications, documents, and contract annexes.
- Manage project documentation, including project plans, status reports, and meeting minutes.
- Create and review supply contracts and control budget/invoices approvals within the defined framework. Escalate issues as necessary.
- Support post-trial reviews and identify opportunities for process improvement.
- Assist the Clinical Supply Manager and Coordinator with other project-related tasks as required.
- Ensure full GMP compliance and documentation for clinical supply activities, including returns, destruction, and full global traceability of Investigational Medicinal Products.
- Participating in project meetings and providing support to coordinate project activities.
- Develop and maintain effective relationships with internal and external partners.
- Preparing project reports, presentations, and other project-related documents.
**Requirements**:
- Bachelor's degree in a scientific or related field.
- Extensive knowledge of English with a good command of the technical vocabulary. Excellent communication skills, both verbal and written, with the ability to communicate effectively with stakeholders at all levels.
- 1-2 years of experience in clinical supplies management or other related fields in the pharmaceutical industry e.g., Manufacturing, Quality Control, Quality Assurance, Regulatory Affairs Logistics or Clinical R&D.
- Understanding of GxP and other regulatory requirements related to clinical supplies.
- Strong attention to detail and a focus on delivering high-quality results.
- Excellent analytical and problem-solving abilities with the ability to work collaboratively in a fast-paced and dynamic environment.
- Detail-oriented, organized, and able to work independently and as part of a team.
- Proficient in Microsoft office tool suite (Word, Excel, and PowerPoint).
- Strong attention to data management skills with a focus on quality of documentation.
- Must be self-motivated with the ability to manage multiple tasks, prioritize, and meet tight deadlines.
**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Expert Clinical Supply Services
Posted today
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Job Description
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.
**Expert Clinical Trial Supply (Team Lead)**
Clinical Trial Supply is a global team of Clinical Supply Managers and Coordinators with offices in Germany, Japan, and China. This year we are going to further diversify our way of working adding a team of Clinical Trial Supply Associates located in India.
Leading a team of Clinical Trial Supply Associates, you will be ensuring high quality and timeliness of the work of your team by providing clear direction, guidance, and support to team members. Focus of the team is supporting the global Clinical Trial Supply team in the execution of clinical trial supply chain activities e.g., ensuring GxP compliant documentation for the certification of investigational medicinal products by a qualified person or in preparation for inspections by authorities.
**Responsibilities**:
- Supervise and support a small team of CTS-Associates and ensuring high quality and timeliness of the work of your team.
- Provide clear direction, guidance, and support to team members, ensuring they understand their roles and responsibilities.
- Ensure full GMP, GDP and GCP compliance of the work of your team
- Collaborate with the team of Clinical Trial Supply Coordinators to manage the clinical supply chain for assigned clinical trials with a focus on ensuring documentation meets GxP standards for inspection purposes.
- Develop and maintain effective relationships with internal and external partners
- Provide support to other members of the Clinical Supplies team as required
- Collaborating with the team on different projects
- Participating in project meetings and providing support to coordinate project activities
- Creating and maintaining project tracking tools
- Preparing project reports, presentations, and other project-related documents
- Handling project-related administrative tasks
- Assisting in the management of project budgets, timelines and ensuring completion of deliverables within budget and time constraints
- Ensure adherence to study budget and escalate issues as necessary
- Other duties as assigned
- Support global clinical supply chain process improvements
- Assist in the maintenance of complete and accurate clinical supply documentation, including batch record review and reconciliation
**Requirements**:
- Bachelor's degree in a scientific or related field
- Extensive knowledge of English with a good command of the technical vocabulary. Excellent communication skills, both verbal and written, with the ability to communicate effectively with stakeholders at all levels.
- 3-4 years of experience in clinical supplies management or other related fields in the pharmaceutical industry e.g., Manufacturing, Packaging, Quality Control, Quality Assurance, Regulatory affairs, Logistics or Clinical R&D
- Experience in participation and leading project teams in the clinical, clinical supply or CMC environment
- Detailed knowledge of international GMP, GDP and GCP rules, and other regulations related to Clinical Trial Materials
- Strong attention to detail and a focus on delivering high-quality results.
- Excellent analytical and problem-solving abilities
- Ability to work collaboratively in a fast-paced and dynamic environment
- Highly motivated, self-starter with the ability to work independently
- Proficient in Microsoft office tool suite (Word, Excel, and PowerPoint)
- Strong attention to data management skills with a focus on quality of documentation
- Must be self-motivated with the ability to manage multiple tasks, prioritize, and meet tight deadlines.
**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Senior Clinical Supply Project Leader
Posted today
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Summary
- This is a universal job description meant to capture some of the primary duties of this role that are common across functions or divisions. It is not intended to represent all of the specific responsibilities of the position -Management TrackLead and manage the Engineering, Logistics and Safety Experts team inthe Local Supply Center to ensure deliveries of intermediates anddrug substance, maintaining compliance with internal and externalregulatory and quality standards(GMP and HSE) and budget targets.Responsible for maintenance and investment budgets and long terminvestment plan for DSS.TRD Representative for Engineering for Rhinetal Valley. -Scientific / Technical TrackHas operational end to end responsibility for assigned supply activities. Leads and manages complex and demanding projects and global network activities and participates in cross-functional teams. Accountable for performance improvement initiatives. -Produces, packages and manufactures drugs to be used in clinical trials. Responsible for distribution, warehousing, transportation, packaging, randomization, blinding, and labeling of material for clinical trials in conformity with guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). -To oversee clinical supply on holistic global trials level, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners.
Major accountabilities:
- Management Track.
- Lead projects or campaigns or proactively drive project execution.
- Set key milestones and /or ensure project progress, quality and budget adherence.
- Act as unit representative on or lead development teams and/or other cross functional teams.
- Ensure governance process is in place to be compliant to Novartis and other relevant regulations.
- Writing and reviewing of SOPs.
- Coaching senior associates in technical and leadership area.
- Act as mentor for senior associates globally.
- Perform role of facilitator/mediator in difficult scenarios.
- Provide strong input into OTR process and Talent Management.
- In close cooperation with the Unit Head, drive the unit long term strategic plan and its implementation.
- Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance.
- Manage resource constraints and lead cost saving opportunities.
- Being accountable for a large budget (Project, infrastructure, plan maintenance).
- Scientific Track.
- Coordinates internal and external stakeholders, customers and /or vendors and performs stakeholder management.
- Lead projects or campaigns or proactively drive project execution.
- Set key milestones and/or ensure project progress, quality and budget adherence.
- Act as unit representative on or lead development teams and/or other cross functional teams.
- Communicate issues to teams and line management in a proactive way and propose corrective actions and mitigation plan.
- Organize and ensure regular lessons learned sessions and follow up on actions.
- Coaching and technical training as recognized technical expert or leader.
- Act as mentor for junior and senior associates (academics) globally.
- Perform role of facilitator / mediator in difficult scenarios.
- Understand resource constraints and identify and lead cost saving opportunities.
- Being accountable for a medium budget (Project, infrastructure, plan maintenance).
- Ensure own and other team members&apos compliance to Novartis and other relevant regulations.
- Writing and reviewing of SOPs.
- Consolidate data evaluation and propose solutions / risk mitigation plans -Act as role model for cultural evolution within TRD.
- Being accountable for global process improvement as leader or member.
- Drive implementation and sustain phase in and outside expertise / organization.
- Oversees clinical supply projects on holistic global trials level, proactively negotiates and communicates clinical supply plan/timeline to internal and external customers and partners.
- Reviews clinical trial protocol and provides input to drug sections.
- Develops packaging design matching the study design, which ensures optimized supply plan in terms of cost, feasibility and overage for own studies and guides and coaches other Trial managers regarding best possible design.
- Applies simulation tools to drive optimal clinical supply plan, adequately supports studies.
- Drives the development and use of simulation technique with ex
- Management Track -Drive the planning, coordination, and execution of all people management processes in the unit, including performance management, training, and development planning.
- Partner with the Development and Education Office (DEO) to identify and devise unit training opportunities, addressing both strategic and behavioral needs while taking into account suitable metrics to quantify training success.
- Drive a culture of excellence in knowledge sharing.
- Provide strong input into OTR process and Talent Management.
- Develop, monitor, and report on Key Performance Indicators (KPI) and performance measures to enable strategic objectives to be met, or corrective action to be taken.
- Permanent measurement, benchmarking, and continuous improvement of KPI for the unit.
- In close cooperation with the Unit Head, drive the unit long term strategic plan and its implementation.
- Ensure current and future needs are fully met, unit projects are assigned, adequately resourced, delivered on time and in full compliance.
- Scientific / Technical Track.
- Quality (GMP), quantity, and timelines for all assigned tasks/projects.
- Compliance with Novartis standards, in particular, ethics, health, safety, and environment (HSE), and information security (ISEC) standards.
- Unit KPIs (e.g. FPFV (first patient first visit), LTA (lost time accident), FTR (first time right), Rework Rates, Recalls).
- Cross functional and TRD KPIs .
Work Experience:
- Collaborating across boundaries.
- Representing the organization.
- People Leadership.
- Continual Improvement Process.
- Master Data.
- Material Requirements Planning (Mrp).
- Materials Management.
- People Management.
- Production Planning.
- Project Management.
- Supplier Relationship Management (Srm).
- Supply Chain Planning.
- Supply-Chain Management.
- Technical Requirements.
- Wms (Warehouse Management Systems).
- English.
Skills Required
Materials Management, Project Management, supply chain planning , Production Planning, technical requirements , People Management
Manager, Global Clinical Supply Chain Compliance Operations, CI&E
Posted today
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Job Description
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Summary:**
The Global Clinical Supply Chain (GCSC) Compliance Manager ensures GxP compliance within GCSC by providing QMS operational support and partnering in business activities, while identifying and supporting process improvements. The role involves managing Global Clinical Supply Chain compliance, monitoring process performance, performing trend analysis and supporting audit/inspection readiness. The incumbent will proactively identify and report to management any operational and systemic compliance issues and/or risks related to clinical supply chain end-to-end processes.
**Key Responsibilities:**
+ Collaborate with GCSC functions to maintain GxP compliance and to support business activities in compliance with procedural requirements.
+ Serve as advisor and functional expert as an accepted body of knowledge and experience in area of expertise.
+ Collaborate with GSC Global process owners in designing, managing, and improving capabilities.
+ Monitor compliance, report performance metrics and perform trend analysis for processes as required.
+ Monitor status of CAPAs to ensure GCSC commitments are met; follow-up as required with e-QMS record owners for the timely completion/extension before their due date
+ Participates in Clinical Supply Chain Quality Council meeting as Data Steward/Metrics SME
+ Own / support eQMS records such as deviations, change controls, CAPAs, pro-active initiatives, stand-alone actions, and risk assessments on behalf of GCSC functions. Perform role of lead investigator for assigned deviation and/or investigational medicinal product quality complaint records as required.
+ Lead GCSC personnel in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies and acting as primary CSC point of contact
+ Conducts root cause analysis to develop responses to audit and inspection findings
+ Collaborate with functional areas to determine best solutions to resolve any identified compliance issues
+ Identifies and escalates technical and/or business issues promptly; must be able to have the ability to solve routine issues independently.
+ Contributes to the development of procedural documents as needed.
+ Support cross-functional/strategic initiatives and continuous improvement projects as assigned
+ Exercise sound judgment, using a risk-based approach, to ensure compliance with regulations, practices, and policies.
+ Contributes to or manage strategic initiatives and continuous improvement projects as assigned.
+ Collects and shares best practices through direct communications and communities of practice.
+ Maintain a contemporary knowledge of current industry trends, standards, and methodologies as it relates to quality systems and management.
+ Travel requirement ~10%
**Qualifications:**
+ Undergraduate/graduate degree in business, science, supply chain management or related field
+ Minimum 5 years in a compliance and/or quality assurance role.
+ Working knowledge GCP/GDP/ GMP and of e-Quality Management systems (eQMS) e.g. Veeva Vault
+ Minimum 3 years' experience in Clinical Supply Chain Management or related field (ex. Interactive Response Technology (IRT), Drug Development, Clinical Operations, etc.)
+ General knowledge of all phases, processes, and functions of drug development.
+ General knowledge of investigational material supply chain processes.
+ Experience working in a highly regulated environment
+ Cross functional collaboration experience developing systems and standard ways of working, digitized metrics and reporting
+ Excellent interpersonal skills
+ Excellent communication skills
+ Technical writing capability
+ Good time management and organizational skills
+ Ability to multi-task numerous projects
+ Ability to work with initiative
+ Ability to achieve targets and milestones
+ Flexible and motivated
+ Data analysis
+ Supply Chain Acumen
+ Confident public speaker
+ Ability to solve routine problems
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1593914
**Updated:** 2025-08-25 04:45:29.044 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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Senior Support Manager, Interactive Response Technology (Clinical Supply Chain)
Posted today
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Job Description
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Job Title/Role** : Sr. Support Manager, Interactive Response Technology
**Department Name/Functional Area** : Global Clinical Supply Chain > Clinical Supply Chain Technologies > IRT
**Location** : Office based **.**
**Position Summary**
+ This position supports multiple IRT studies (system development, study management, change management, audits and data provisioning). Supports UAT Services organization as required. Identifies areas of process improvement and participates or leads these initiatives.
**Duties/Responsibilities**
+ Lead successful maintenance support and projects to ensure execution and on time delivery of Interactive Response Technology (IRT) changes, data and support integrations with other clinical systems (e.g., Depots, Central Lab, and EDC), such that the resultant IRTs are fit-for-purpose as defined by protocol and study operational parameters with special emphasis on adherence to BMS standards and quality principles.
+ Works independently and assume support role responsibilities on assigned projects. Collaborate with the IRT Team where necessary to ensure BMS standards and/or for requests by study teams that are not within these standards or best practice are addressed.
+ Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.
+ During IRT maintenance act as the primary contact for assigned studies for the cross-functional study team and vendor. Additionally, provide timely response to all randomization/IRT issues (including data integrations and delivery) that arise during IRT lifecycle and ensure they are resolved.
+ Maintain vendor performance quality events in ADI log.
+ Act as off hours audit/inspection support contact as needed to support rest of world.
+ Responsible for generation and oversight of patient and container randomization schedules, ensuring parameters reflect the protocol and drug supply requirements. Distribute patient randomization and container schedules as appropriate to Clinical Supply P&L and IRT vendors.
+ Manage special project implementation by identifying project needs, tracking, implementation, and reporting to a central project team.
+ Bring issues of concern or system failure to the immediate attention of the IRT Leadership Team.
+ Support IRT improvement initiatives and manages improvement projects that impact daily operations to improve efficiency."
+ Support key department and enterprise level initiatives as part of the IRT representative."
+ Ensure on time delivery of maintenance support and may be involved in user acceptance testing of IRT systems per BMS SOPs and procedures, write or review User Acceptance Test Plan and causes to ensure thorough testing of high -risked areas and new functionality documented in the user requirements.
+ Ensure systems and associated documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, ICH E6 (R2) as well as in accordance BMS SOPs and processes."
+ Ensure effective system access and functionality across all countries and all user locations.
+ Complete all assigned training by due date
+ Support unblinding activities as needed.
+ Ensure on time development of IRT data transfers with vendors and/or third-party vendors.
+ Ensure eTMF compliance at the study level in accordance with group and BMS guidance.
+ Engage and support study and CSMT project teams as deemed necessary.
+ Ensure delivery of data to BMS departments and third-party vendors consistent with BMS SOPs and forms.
+ Additional tasks within scope of expertise and experience as assigned by the supervisor in pursuit of BMS goals.
**Reporting Relationship**
+ This position reports to the Associate Director, Interactive Response Technology (IRT).
**Qualifications**
+ Minimum bachelor's degree
+ Minimum of 3 to 5 years work experience preferably in a health science or related IRT industry (pharmaceutical, hospital-based, laboratory, etc.)
+ Demonstrated analytical skills and a working knowledge of Microsoft Office including SharePoint.
+ Clinical Research experience
+ Working knowledge of IRT
+ Working knowledge of Clinical Trial Management Systems
+ Working knowledge of clinical supplies
+ Able to think outside of the box, have excellent communication and analytical skills to successfully deliver optimal IRT solutions across a diverse and dynamic portfolio.
+ Understand the nature of clinical data and concepts of IRT study design and configuration, resupply settings, blinding, privacy protection, and data quality/integrity standards.
+ Exposure to working in a GMP / GCP environment and with regulatory audit teams.
+ Possess excellent English language written and verbal communication, interpersonal, collaboration and business partnership capabilities required
+ Comfortable working with a global team, partners and customers in a change agile environment
+ MS Project, MS Visio, or any other requirements visualization and analysis tools)
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R1591255
**Updated:** 2025-08-25 04:45:29.044 UTC
**Location:** Hyderabad-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Manager, Global Clinical Supply Chain Compliance Operations, CI&E
Posted today
Job Viewed
Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Position Summary:
The Global Clinical Supply Chain (GCSC) Compliance Manager ensures GxP compliance within GCSC by providing QMS operational support and partnering in business activities, while identifying and supporting process improvements. The role involves managing Global Clinical Supply Chain compliance, monitoring process performance, performing trend analysis and supporting audit/inspection readiness. The incumbent will proactively identify and report to management any operational and systemic compliance issues and/or risks related to clinical supply chain end-to-end processes.
Key Responsibilities:
Qualifications:
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Senior Support Manager, Interactive Response Technology (Clinical Supply Chain)
Posted today
Job Viewed
Job Description
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Job Title/Role : Sr. Support Manager, Interactive Response Technology
Department Name/Functional Area : Global Clinical Supply Chain > Clinical Supply Chain Technologies > IRT
Location : Office based.
Position Summary
Duties/Responsibilities
Reporting Relationship
Qualifications
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.