36 Clinical Documentation Manager jobs in India

Role: Clinical Data specialist

Skill: CDM, Rave

Mode: Hybrid

Experience: 2-5 years in Clinical Data management

Job Location: Kochi/Kolkata

Educational Qualification: Any life science graduate

Job Overview:

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.

Essential Functions

• Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
• May serve in the role of back-up to a DOC or DTL.
• May conduct data review.
• May write and resolve data clarifications.
• May lead database audit team.
• May develop and test databases and edit specifications.
• May perform testing of programming.
• May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."

Qualifications

• Bachelor's Degree Clinical, biological , or related field Req
• Equivalent combination of education, training and experience in lieu of degree.

Role: Clinical Data specialist

Skill: CDM, Rave

Mode: Hybrid

Experience: 2-5 years in Clinical Data management

Job Location: Kochi/Kolkata/Bangalore

Educational Qualification: Any life science graduate

Job Overview:

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.

Essential Functions

• Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
• May serve in the role of back-up to a DOC or DTL.
• May conduct data review.
• May write and resolve data clarifications.
• May lead database audit team.
• May develop and test databases and edit specifications.
• May perform testing of programming.
• May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team."

Qualifications

• Bachelor's Degree Clinical, biological , or related field Req
• Equivalent combination of education, training and experience in lieu of degree.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
**Job Description**
The Clinical Data Team Lead (CDTL) position at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.) offers an exceptional opportunity to work with a global team and lead world-class data management projects that drive scientific research forward. As a CDTL, you will serve as the lead data manager for one or more projects, emphasizing flawless execution and strict adherence to project protocols.
Key Responsibilities
+ Lead all data management activities for individual, limited volume/complexity studies with support from senior team members.
+ Act as an interdepartmental liaison to the Project Lead and/or client as required and communicate with management regarding all data management (DM) activities within their studies.
+ Apply relevant components of the project protocol to daily tasks and direct others on how to apply them.
+ Develop and maintain data management project documentation files; perform independent reviews of data management deliverables following documented CDM guidelines.
+ Serve as the point person and subject matter expert for specialized study-specific processes.
+ Develop and deliver study-specific training for DM project staff. Mentor junior level staff on all associated tasks within a study.
+ Produce project-specific status reports for management, Project Lead, and/or clients on a regular basis. Monitor study metrics.
+ Contribute to the improvement of data management processes on a global level.
+ Participate in business development activities by assisting with bid preparation and/or representing data management at bid defense meetings, where required.
+ Assist with project forecasting of hours and identification of resource requirements. Identify potential out-of-scope activities to Project Lead and management and assist with the Contract Modification process.
+ Assist with the administrative and financial management of allocated projects. Perform all assigned data management activities independently and efficiently, with attention to quality.
+ Perform data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations, as well as Data Listing reviews.
+ Perform advanced aspects of the data cleaning process with high accuracy, in accordance with GCPs and SOPs/WPDs, to assess the safety and efficacy of investigational products and/or medical devices.
+ Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
+ Develop professional expertise, applying company policies and procedures to resolve a variety of issues.
+ Receive general instructions on routine work and detailed instructions on new projects or assignments. Exercise judgment within defined procedures and practices to determine appropriate action.
+ Build productive internal/external working relationships, with contacts primarily internal to the company and infrequent external customer/vendor contact on routine matters.
Education and Experience
+ Bachelor's degree or equivalent formal academic qualification.
+ Minimum of 6+ years of experience in data management or a related field.
+ Combination of education, training, and relevant experience may be considered sufficient.
Knowledge, Skills, and Abilities
+ Apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs, and client expectations.
+ Strong attention to detail, numerical skills, and proficiency with interactive computer programs, including Microsoft Office applications.
+ Excellent written and verbal communication skills with a strong command of the English language and grammar.
+ Good organizational, analytical, and problem-solving skills, capable of working productively with moderate supervision.
+ Fast and agile learner, capable of quickly adapting to new information and environments, including the use of Generative AI tools.
+ Effective interaction with global teams, demonstrating strong interpersonal skills, cultural awareness, and a strong customer focus.
+ Ability to train and direct study team.
+ Ability to set and meet timelines or recognize and schedule changes in response to project demands.
+ Proactive and self-motivated, with excellent time management skills and the ability to organize tasks efficiently and adhere to schedules.
+ Experience with DM EDC databases, particularly Medidata Rave and Veeva Vault, and knowledge of good documentation practices such as eTMF.
+ Ability to maintain a high degree of confidentiality with clinical and proprietary data.
+ Flexibility and adaptability, capable of working in a team environment or independently, demonstrating good judgment in decision-making.
+ Knowledge of medical/clinical trial terminology and understanding of project protocols and Data Validation Manual.
Working Conditions
+ The standard working hours are from 1:00 PM to 10:00 PM IST.
+ Employees have the flexibility to choose between office, remote, or hybrid work options.
Join us in our mission to make the world healthier, cleaner, and safer by successfully implementing your expertise in data management. Apply today and become part of our ambitious team at Trialmed (a global site network and the early phase clinical solution for PPD, the clinical research business of Thermo Fisher Scientific Inc.).
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Clinical Data Science Assistant - Bangalore India - Immediate Joiners
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Data Science Assistant to join our diverse and dynamic team. As a Clinical Data Science Assistant at ICON, you will play an essential role in supporting data science activities related to clinical trials. The role supports data management project teams within Global Development and provides administrative and project support to access management workflows, process improvement project teams, other leaders/teams as assigned.
This role supports data management project teams within Global Development and provides administrative and project support to access management workflows, process improvement project teams, other leaders/teams as assigned.
**Job Responsibilities:**
+ Manage database access for Data Management, events and meetings, perform archiving activities for assigned studies.
+ Directly administer the database access interface based on request form workflows (EDC, SharePoint, other data systems).
+ File data management documents from legacy studies into the Trial Master File.
+ Answer clients' queries about database access, escalate issues to supervisors or senior team members.
+ Maintain and update records/reports of users' access.
+ Attend events and record project team output as assigned.
+ Develop and maintain working knowledge of communication devices and applications to enable tech savvy meetings without interruption.
+ Support projects in tandem with Data Management Operations Leaders.
+ Contribute to project plans based on subteam output.
+ Build project team folders and granting access in Share Point.
+ Work with Leads to work throughout checklist for each project; execute assigned tasks with minimal direction.
+ Manage metrics as assigned, update project metrics reports for leader updates.
+ Manage Data Management Operations/Access Management calendar/inbox.
+ Coordinate basic workflows within the department and may help streamline processes; make recommendations for solutions to issues.
+ Use judgment to escalate issues to the appropriate team members for consideration and resolution.
+ Update SharePoint department page(s).
+ Work with supervisor to act as a point person for all new employees within the department(s), coordination with IT, Facilities, and Procurement, communicates with space planning.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
**Responsibilities may include the following and other duties may be assigned.**
**Minimum 6+ years of experience.**
**Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.**
**Design and implement clinical protocols and data collection systems.**
**Develops systems for organizing data to analyze, identify and report data and trends.**
**Manages data management issues by reviewing protocols for cross-project consistency, and identifying standard Case Report Form (CRF) modules to meet objectives.**
**Develops data quality plans.**
**Provide early strategic input into protocol design focused on data management issues.**
**Review and resolve data discrepancies for standardized data validation systems and procedures.**
**Prepares reports of clinical trial studies for internal validation and cross validation studies.**
**SPECIALIST CAREER STREAM:** **Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.**
**DIFFERENTIATING FACTORS**
**Autonomy:** **Established and productive individual contributor.**
**Works independently with general supervision on larger, moderately complex projects / assignments.**
**Organizational Impact:** **Sets objectives for own job area to meet the objectives of projects and assignments.**
**Contributes to the completion of project milestones .**
**May have some involvement in cross functional assignments.**
**Innovation and Complexity:** **Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .**
**Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.**
**Communication and Influence:** **Communicates primarily and frequently with internal contacts .**
**External interactions are less complex or problem solving in nature.**
**Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.**
**Leadership and Talent Management:** **May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.**
**Required Knowledge and Experience:** **Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.**
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email

The Clinical Data Engineer role serves the purpose of fostering innovation and operational efficiency through the facilitation of data-driven decision-making processes, expediting drug discovery initiatives, and bolstering regulatory compliance efforts. This role involves designing and implementing customized data pipeline architecture solutions tailored to the complexities of life sciences research and development. It also includes supervising the integration and management of various clinical data and data sources, such as clinical trials data, operational data, lab data, wearables data, and real-world evidence.
Through close collaboration with study leads, research scientists, statisticians, clinicians, regulatory experts, and DigitalX professionals, this role establishes and upholds robust data architecture frameworks that align harmoniously with business objectives, regulatory mandates, and industry standards. Expertise in Data Engineering, Data Modeling, and adeptly managing governance processes is essential for maintaining the integrity, security, and accessibility of data assets. This role holds a strategic position in advancing the life sciences company's mission by using data to drive scientific progress, improve patient outcomes, and efficiently and securely introduce ground-breaking therapies to the market.
This position is based in Bengaluru and will require some on-site work.
Responsibilities and Accountabilities:
· Responsible for data operations on AWS architecture. Activities include creating and monitoring the data load ETL processes, ensuring data quality, automation of the loads and continuous improvement.
· Collaborate with internal and external teams for data curation, cataloging and metadata management.
· Strong knowledge of RWD assets including data sources like IQVIA, SYMPHONY and various other OMICS sources.
· Ensure the operations schedule and knowledge base are maintained and communicated promptly to the end users.
· Assist in enforcing data governance and information management policies, SOPs, and standards to manage patient data in a secure and compliant manner.
· Strong proficiency in Python and Django framework including experience with web technologies such as HTML, CSS, JavaScript, and AJAX.
· Understanding of RESTful APIs and web services integration. Additionally, Familiarity with deployment tools such as Docker, Heroku, AWS, or Azure.
· Knowledge of database management systems, particularly PostgreSQL or MySQL.
· Experience with unit testing and test-driven development (TDD).
· Experience with JavaScript frameworks like React, Angular, or Vue.js and other modern API technologies.
· Identify areas for improvement with current analytics tool sets and propose future state to support DigitalX use cases, analytics best practices, and regulations.
· Improving the delivery of large complex projects by implementing standard processes, tools, and templates that will be used consistently across Digital.
· Participate in several concurrent projects in Advanced Analytics Solutions for the various functions across Astellas in a fast-paced environment.
· Ensure the RWD Analytics environments are running at an optimal state and quickly resolve any technical issues.
· Participate in process improvements initiatives involving business areas.
· Collaborate with Advanced Analytics Solution teams to identify required technology architecture needs to design and implement a solution delivering near-term impact and aligned with long term strategies.
· Implement security requirements, metadata standards, data quality and testing procedures for the data lake/warehouse consistent with analytic and RWD best practices.
Required Qualifications:
· Bachelor of Science degree in Computer Science, Information Systems, Data Science, or a related field.
· 5+ years of relevant experience working in in data architecture, engineering roles or related roles within a healthcare industry.
· Data architecture and engineering experience
Preferred Qualifications:
· Master of Science degree in Computer Science, Information Systems, Data Science, or a related field.
· 3+ years' experience in Life Sciences industry
· Expertise in ETL, data modelling, and data integration techniques.
· Proficiency in programming languages commonly used in RWD data ingestion, such as Python, and Django framework.
· Expertise in working with web technologies such as HTML, CSS, JavaScript, and AJAX
· Strong command in RESTful APIs and web services integration.
· Knowledge of database management systems, particularly PostgreSQL or MySQL
· In-depth understanding of life sciences business processes, adept at translating business requirements into effective technical solutions.
· Innovative problem-solving abilities for addressing complex data-related challenges.
· Experience with Agile methodology and mindset.
· Excellent communication and interpersonal skills, enabling effective collaboration with cross-functional teams, business stakeholders, and technical experts.
· Project management capabilities, ensuring adherence to timelines for successful solution delivery.
· Relevant certifications in cloud computing and data engineering tools/platforms are advantageous.
Category Bold X
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans

**Director Clinical Data Management**
**Live**
**What You Will Do**
Let's do this. Let's change the world. The Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team on the aspiration of optimizing and delivering an industry admired clinical evidence platform to deliver innovative medicines to patients with unmet medical needs.
The Director is accountable for leadership and oversight of the data management organization; ensuring operational excellence and consistency in clinical trial execution. They are accountable for building and developing a high performing internal data management team, as well as ensuring engagement and alignment of Amgen's strategy and priorities with the Functional Service Provider (FSP).
The Director is also part of the Global Study Operations (GSO) leadership team, accountable for the delivery of quality clinical trials through industry-leading execution of innovative processes, strong cross-functional partnerships, and best-use of clinical systems and analytics to guide site and study operations. The role will support acceleration of clinical programs and other continuous improvement efforts, applying innovative thinking in shaping future strategy.
Our Global Clinical Data Management Team:
The Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization and reporting into the Executive Director, Global Study Operations, work together to meet the demands of an industry leading, fast paced, high throughput organization with a commitment to compliance, quality and standards.
Director Clinical Data Management role overview:
You will lead and manage Data Management (DM) teams within a specific DM operational business unit. The Director will set and drive forward the vision and strategy for DM as a member of the DM and GSO Leadership Team.
Responsibilities:
+ Oversight of a distinct DM operational unit (e.g. therapy area, cross-product area)
+ Recruiting, managing and developing staff
+ Global resource planning and assignments
+ Setting of functional goals and objectives
+ Creating and implementing GSO & DM strategies developing, reviewing, implementing and enforcing data standards
+ Ensuring DM processes/systems meet regulatory and business requirements
+ Be an active member of the Leadership Team to provide a foundation for GSO success
Key activities will include:
+ Team management including performance, coaching and development
+ Develop, review and implement policies, SOPs and associated documents affecting DM globally
+ Set vision, strategy and direction for DM group; develop annual goals and objectives
+ Accountable for and oversee DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSP
+ Define and maintain Service Level Agreements and Key Performance Indicators; including oversight of quality and CAPA management
+ Governance oversight -ensure visibility into performance of FSPs to the department
+ Sponsor, Lead and participate in cross functional working groups
+ Resource and budget management for global function Ensure adequate training and capability within area and be accountable for staff compliance with all DM processes
+ Vendor management (development of strategies, contract management, relationship management, etc)
+ Respond to audit/inspection findings
+ Be accountable for and oversee all study deliverables and submission activities for products within group
+ Ensure that status information on DM activities is available and is acted on as needed
**Win**
**What We Expect Of You**
We are all different, yet we all use our unique contributions to serve patients. The data management professional we seek is a collaborator with these qualifications.
Basic requirements:
+ **18 to 23** years of data management experience
Preferred Experience:
+ Master's degree or equivalent in life science, computer science, business administration or related discipline
+ 10+ years of extensive experience in data management in the Pharmaceutical or Biotech arena
+ 8+ years of experience in rare disease therapeutic area, in a leadership role
+ Broad experience of working in a global organization
+ Experience at or oversight of outside vendors (CRO's, central labs, imaging vendors, etc)
+ 8+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
+ Strategic and innovative thinker with experience of driving operational excellence
+ Excellent relationship building skills with the ability to influence and make business impact
+ Ability to work collaboratively cross functionally with ability to influence and drive decisions
+ Proven experience within oversight of clinical research suppliers
+ Project management
+ Previous experience in a global, matrix organization
+ Excellent organizational and interpersonal skills
+ Ability to anticipate and problem solve challenging issues

**JOIN AMGEN'S MISSION OF SERVING PATIENTS**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Associate Vice President, Clinical Data Management**
**Live**
**What you will do**
Let's do this. Let's change the world. The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization.
**The AVP will lead Amgen's Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases.**
This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards.
The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment.
**Responsibilities:**
+ **Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals.**
+ **Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases.**
+ **Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows.**
+ Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums.
+ Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance.
+ **Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization.**
+ Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues.
+ Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions.
+ Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics.
+ Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data.
+ Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence.
+ Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs.
+ Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function.
+ Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies.
+ Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines.
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.
**Basic Qualifications:**
+ **Bachelor's or master's degree with 25+ years of data management experience AND**
+ **10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources**
**Preferred Qualifications:**
+ Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment.
+ **Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM).**
+ Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen's global clinical development efforts.
+ Expertise in AI/ML-driven data management solutions, automation, and advanced analytics.
+ **Understanding of clinical data standards (CDISC, SDTM, ADaM).**
+ **Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions**
+ Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management.
+ Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams.
+ **Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE).**
+ **Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA).**
+ Familiarity with decentralized trial models and digital health technologies.
They will also embody the Amgen leadership attributes which are:
+ **Inspire:** Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
+ **Accelerate:** Enable speed that matches the urgency of patient needs by encouraging progress over perfection
+ **Integrate:** Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
+ **Adapt:** Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.