13 Nursing Management jobs in India
Patient Care Specialist
Posted 5 days ago
Job Viewed
Job Description
Location: Hyderabad, TG
About Marbles Health
Marbles Health is a brain healthcare company redefining standards of care across psychiatry and neurology. Our flagship innovation, EASE, is India’s first medically licensed portable neuromodulation system—pioneering safer, more effective, and scalable brain healthcare for millions. We are building the future of mental and neurological care, combining science, technology, and compassion.
As a Patient Care Specialist & Sales Representative , you will be responsible for two things
1. Primarily, delivering EASE therapy sessions using our tDCS device - EASE, directly in patients homes. You will act as a vital link between patients and their psychiatrists, ensuring consistent treatment delivery, adherence tracking, reporting and compassionate care.
2. Following up with doctors to get Patient Referrals for home based treatment, Giving device demos, etc.
Role & responsibilities
- Travel to patient residences to administer prescribed sessions using the EASE device.
- Educate patients and caregivers about device use and treatment goals.
- Record session data, monitor adherence, and report any concerns using app-based tools.
- Collaborate regularly with assigned doctors and clinical teams to update on patient progress.
- Offer basic emotional support and encouragement to patients during therapy.
Preferred candidate profile
- Graduate Degree in a Medical or a Business Field
- Valid drivers license and willingness to travel everyday extensively.
- Own car/bike
- Proficiency in using Tech interfaces
- Fluency in English and local language - Kanada in Bangalore & Telugu in Hyderabad
- Strong interpersonal skills with a naturally empathetic personality.
Patient Care Specialist
Posted 5 days ago
Job Viewed
Job Description
Location: Bengaluru, KA
About Marbles Health
Marbles Health is a brain healthcare company redefining standards of care across psychiatry and neurology. Our flagship innovation, EASE, is India’s first medically licensed portable neuromodulation system—pioneering safer, more effective, and scalable brain healthcare for millions. We are building the future of mental and neurological care, combining science, technology, and compassion.
As a Patient Care Specialist & Sales Representative , you will be responsible for two things
1. Primarily, delivering EASE therapy sessions using our tDCS device - EASE, directly in patients homes. You will act as a vital link between patients and their psychiatrists, ensuring consistent treatment delivery, adherence tracking, reporting and compassionate care.
2. Following up with doctors to get Patient Referrals for home based treatment, Giving device demos, etc.
Role & responsibilities
- Travel to patient residences to administer prescribed sessions using the EASE device.
- Educate patients and caregivers about device use and treatment goals.
- Record session data, monitor adherence, and report any concerns using app-based tools.
- Collaborate regularly with assigned doctors and clinical teams to update on patient progress.
- Offer basic emotional support and encouragement to patients during therapy.
Preferred candidate profile
- Graduate Degree in a Medical or a Business Field
- Valid drivers license and willingness to travel everyday extensively.
- Own car/bike
- Proficiency in using Tech interfaces
- Fluency in English and local language - Kanada in Bangalore & Telugu in Hyderabad
- Strong interpersonal skills with a naturally empathetic personality.
Patient Care Executive
Posted 9 days ago
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Job Description
Roles & Responsibilities
(Defines the prime focus areas of the job)
Patient Care Management
Receive patients with warmth and provide a comfortable atmosphere for assessment and treatment.
Provide info related to services and tariff to the patients.
Orients and educates patients and their families by explaining the care plans and other information relating to the treatments.
Pre and post-counseling for the patients undergoing the treatment plans if required.
Address and resolve patient complaints and concerns promptly and effectively.
Understand and action accurate data entry on a daily basis
Handling Appointments
Understand the CRM platform
Comprehend detailed nuances around therapist availability and accordingly block appointments
Maintain data related to financial transactions, patient flow, and individual patient visits.
Track patient's journey from lead status to discharge and follow-ups
Patient Experience Enhancement
Respect patients by recognizing their rights; and maintaining confidentiality.
Collect patient testimonials and feedback as per organizational policy.
Monitor and evaluate patient care metrics, identifying areas for improvement.
TAT of 30 mins to be adhered for all the calls received
Coordination and Collaboration
Responsible to follow up on the assessment report till it gets delivered to the patient
Work closely with the sales team to promote patient care initiatives and success rate
Increase in conversion ratio will be reviewed in constant interval
Quality Improvement
Monitor delivery of care by documenting; identifying progress toward desired care outcomes; intervening to overcome deviations in the expected plan of care; and reviewing the care plan.
International Patient Care Hospital Assistant
Posted 4 days ago
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Job Description
About Us:
Inmedism® is a leading healthcare facilitator dedicated to providing top-tier medical care and support to patients from around the world. Our commitment to international patient care is at the heart of our mission, and we are looking for a passionate Hospital Assistant to join our team. Our excellence extends not only to our medical services but also to the compassionate and personalized care we provide to each patient.
Job Description:
As an International Patient Care Executive at Inmedism®, you will play a pivotal role in ensuring that our international patients receive the highest quality of care and support during their medical journey with us. You will be the welcoming face and comforting presence that makes a significant difference in our patients' experiences.
Key Responsibilities:
1. Patient Liaison: Act as the primary point of contact for international patients, ensuring their needs, concerns, and questions are addressed promptly and professionally.
2. Cultural Sensitivity: Display a deep understanding and appreciation of cultural differences, offering a welcoming and inclusive environment for patients from diverse backgrounds.
3. Hospital Orientation: Provide international patients with comprehensive orientations, helping them understand hospital procedures, services, and facilities.
4. Language Support: Provide language assistance, translation, or interpretation services as needed to facilitate clear communication between patients and healthcare providers.
5. Assistance with Administrative Processes: Help patients with paperwork, including admissions, insurance claims, and billing inquiries, making their administrative processes as smooth as possible.
6. Patient Advocacy: Advocate on behalf of patients to ensure their concerns and needs are addressed promptly and appropriately by the medical team.
7. Crisis Management: Be prepared to assist patients and their families during medical emergencies, offering emotional support and helping to coordinate necessary services.
8. Caring Support: Provide emotional support to patients who may be far from home, offering a reassuring presence during their medical journey.
9. Quality Assurance: Collaborate with the healthcare team to ensure that international patients receive high-quality care that meets or exceeds international standards.
10. Patient Satisfaction: Monitor patient feedback and take proactive steps to enhance patient satisfaction. Address any issues or concerns promptly and professionally.
Qualifications:
- Previous experience in a healthcare or customer service role is preferred.
- Bachelor's degree in a relevant field (e.g., Healthcare Management, International Relations, Languages) preferred.
- Excellent interpersonal and communication skills.
- Proficiency in English, Hindi and one or more foreign languages (e.g., Bengali, Arabic, Russian, French, Spanish) is highly desirable.
- Cultural sensitivity and empathy.
- Ability to remain calm under pressure.
- Strong organizational and problem-solving abilities.
- Knowledge of medical terminology and procedures is advantageous but not mandatory.
Salary Package:
- We offer a competitive salary package, commensurate with your skills and experience.
Employee Benefits:
- Competitive salary package
- Performance-based incentives
- Opportunity to work with top Indian hospitals
- Exposure to global healthcare operations
- Supportive and collaborative work environment
How to Apply:
If you are a compassionate, empathetic individual who is excited about contributing to the well-being of international patients, we encourage you to apply for this rewarding position. Please submit your resume and why you are a suitable candidate for this role to “ ” with the subject line: “Application for International Patient Care Executive – (Your Name)”
We welcome applications from candidates of all backgrounds and experiences.
Join us in making a difference in the lives of patients from around the world. Your care and dedication can truly change lives.
Patient Care Exec @Home Care(Aviation/Hospitality)
Posted 16 days ago
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Job Description
Job Title: Patient Care Executive Home Care Department, preferable from Aviation or hospitality sector
Department: Hospital @Home / Home Care
Location: Charni Road, Mumbai
Reporting To: Manager Hospital @Home Services
Shift Timings: Rotational Shifts (Last shift ends at 10:00 PM)
Employment Type: Full-Time
Job Summary:
The Patient Care Executive will be responsible for executing and delivering a seamless patient experience for the Hospital @Home services. The role requires end-to-end coordination with patients, clinicians, and internal departments to ensure timely scheduling, communication, and service fulfillment. The incumbent will play a key role in representing the hospitals brand and ensuring adherence to service excellence standards.
Qualifications & Experience:
- Full-time Graduate in any discipline (Healthcare, Hospitality, or Aviation preferred)
- Minimum 1 year of relevant experience in a customer-facing role, preferably from the hospitality or aviation sector
- Excellent verbal and written communication skills
- Proficient in MS Office and basic hospital management systems
- Willingness to work in rotational shifts including late evenings
Key Responsibilities:
1. Patient Experience & Service Coordination:
- Execute the Patient Experience Service Delivery Model to ensure high-quality service across all touchpoints
- Counsel patients and their families regarding service offerings , inclusions, exclusions, and answer all queries effectively
- Represent the hospital brand and uphold its mission, vision, and values in every interaction
2. Scheduling & Communication:
- Manage and monitor the scheduling of Hospital @Home appointments ensuring accuracy and timeliness
- Ensure prompt communication of any appointment changes, cancellations, or delays via SMS, email, or calls with documented reasons
- Provide accurate information and proper redirection to patients during service inquiries
3. Turnaround Time (TAT) & Escalation Management:
- Monitor and ensure adherence to defined TATs for registration, billing, query resolution, and other KPIs
- Maintain and update departmental dashboards and proactively flag delays or process deviations to the Manager
- Escalate unresolved or complex issues appropriately while ensuring patient satisfaction
4. Billing & Documentation:
- Verify bills and payment collection at the point of service; highlight discrepancies and share daily reports of incomplete transactions
- Ensure scanning and uploading of all relevant documents in the EMR/billing system for compliance and audit trail
- Maintain clear, complete, and accurate service records
5. Quality, Grooming & Protocol Adherence:
- Ensure grooming, telephonic communication, and etiquette standards are followed as per hospital policy
- Uphold protocols for handling patients and attendants/visitors with courtesy and professionalism
- Continuously strive to meet and exceed Net Promoter Score (NPS) and patient satisfaction benchmarks
6. Shift Operations & Coverage:
- Work across all three shifts to ensure 24/7 coverage and continuity of services for Hospital @Home clients
- Maintain seamless handovers and communication between shifts to support uninterrupted care delivery
Key Competencies:
- Service Orientation & Empathy
- Communication & Interpersonal Skills
- Attention to Detail & Time Management
- Problem-Solving and Escalation Handling
- Digital Literacy & Documentation Accuracy
- Professionalism and Brand Representation
Elder Care Coordinator - Patient Support Services
Posted 10 days ago
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Job Description
Responsibilities:
- Conduct comprehensive needs assessments for elderly individuals.
- Develop and implement personalized care plans tailored to individual needs and preferences.
- Coordinate and arrange for various support services, including healthcare, home care, and social activities.
- Liaise with healthcare professionals, family members, and community resources to ensure integrated care.
- Monitor client well-being and the effectiveness of care plans, making necessary adjustments.
- Provide emotional support and companionship to clients.
- Assist clients and families with navigating healthcare systems and social services.
- Manage case documentation, including client records, progress notes, and service logs.
- Advocate for the rights and needs of elderly clients.
- Organize and facilitate community-based programs for seniors.
- Diploma or Bachelor's degree in Social Work, Gerontology, Nursing, or a related field.
- Minimum of 3 years of experience in elder care, case management, or a related social service role.
- In-depth knowledge of services and resources available for seniors.
- Excellent communication, interpersonal, and empathetic listening skills.
- Strong organizational and time-management abilities.
- Ability to work effectively under pressure and manage multiple cases.
- Proficiency in record-keeping and basic computer skills.
- A genuine passion for working with and supporting the elderly.
Remote Senior Care Coordinator - Patient Advocacy Lead
Posted 18 days ago
Job Viewed
Job Description
Responsibilities:
- Develop, implement, and manage individualized care plans for senior clients.
- Coordinate appointments with healthcare providers, specialists, and therapists.
- Facilitate communication between clients, families, healthcare professionals, and service providers.
- Act as a patient advocate, ensuring clients' needs and preferences are met.
- Assess clients' needs and connect them with appropriate community resources and support services.
- Maintain detailed and confidential client records, including progress notes and service logs.
- Monitor client well-being and proactively address any emerging concerns.
- Educate clients and families about available healthcare options and services.
- Ensure compliance with all relevant healthcare regulations and organizational policies.
- Conduct virtual client assessments and follow-up consultations.
- Liaise with insurance providers and assist with benefits navigation.
- Document all interactions and service delivery meticulously.
- Bachelor's degree in Social Work, Nursing, Gerontology, Public Health, or a related field.
- Minimum of 3 years of experience in case management, social work, or senior care coordination.
- Demonstrated experience in patient advocacy and navigating healthcare systems.
- Proficiency in using remote communication tools and Electronic Health Records (EHR) systems.
- Excellent interpersonal, communication, and active listening skills.
- Strong organizational skills with the ability to manage multiple caseloads efficiently.
- Empathy, patience, and a genuine passion for serving seniors.
- Knowledge of community resources for seniors and their families.
- Ability to work independently and manage time effectively in a remote setting.
- Understanding of HIPAA and other relevant privacy regulations.
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Director, Clinical Data Management
Posted 2 days ago
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Job Description
**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
AVP, Clinical Data Management
Posted 2 days ago
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Job Description
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.
Associate Director, Clinical Program Management
Posted 2 days ago
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Job Description
**Job Description**
**_OBJECTIVES/PURPOSE_**
+ Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan (CDP).
+ In close collaboration with Clinical Operations Program Lead (COPL) and Clinical Study Manager (CSM):
+ Responsible for oversight of the execution of studies in the assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
+ Oversight of strategic CRO partners and/or other vendors to meet Takeda's obligations described in ICH-GCP and Takeda's business objectives.
+ Represent Clinical Operations to contribute to CDP by providing regional operational expertise and strategic, inputs including study feasibility, budget, and timeline for assigned clinical programs
**_ACCOUNTABILITIES_**
+ Accountable for developing regional operational strategy for assigned clinical studies.
+ Contribute to the translation of CDP into an optimal operational strategy and plan. Lead assessment of various scenarios operational for optimal execution of CDP.
+ Collaborate with key investigators to reflect feasible and realistic operational inputs to CDP and ensure timeline and quality of studies meet the needs of CDP.
+ Provide subject matter expertise and operational input into protocol synopsis and protocol, obtaining opinions in terms of study execution from key investigators, as appropriate.
+ Challenge study team to ensure that operational feasibility, inclusive of patient and site burden and that timelines meet the needs of CDP.
+ Validate budget and ensure impacts are adequately addressed.
+ Participate in site selection process, with a focus on providing country insights, and therapeutic expertise to ensure alignment between study execution plan and program strategy.
+ Responsible for clinical study budget planning and management, and accountable for external spending related to clinical study execution. Works closely with relevant stakeholders (strategic CRO partners, other vendors, CSM, COPL, and Program Management, Outsourcing, and Finance) to ensure the accuracy of budget spending on a regular basis.
+ Oversee strategic CRO partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical studies in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversight includes but is not limited to:
+ Review and approval of key risk-based monitoring documents/plans, periodic review of outputs, decisions, and actions related to risk-based monitoring.
+ Documented review and monitoring of issues, risks and, decisions at the study level.
+ Support the identification of trends across sites and/or the study.
+ Review and provide clinical operations expertise into clinical documents related to the drug development process:
+ Creation and maintenance of clinical trial materials, such as Investigator Brochures, study synopsis & protocols, clinical study reports, etc.
+ Preparation of key regulatory meetings, as appropriate.
+ Collaborate with cross-functional counterparts and strategic CRO partners/other vendors to ensure inspection readiness and lead Clinical Operations aspects of inspection readiness activities and act as subject matter expert during regulatory inspections.
+ Actively seek new ways of working more efficiently to meet the needs of clinical development, such as cost-reduction, time-savings, efficiency, and quality.
+ Participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
+ Responsible for talent development, including training and mentoring less experienced staff.
+ Seek an efficient way to maximize operational excellence in the cross-regional collaboration (e.g. Japan & Asia) with innovative ideas.
**_CORE ELEMENTS RELATED TO THIS ROLE_**
**Program**
+ Provide operational expertise and strategic inputs to the development of CDP and lead assessment of various operational scenarios for optimal execution of CDP.
+ Recognized as a clinical operations expert by other functions and stakeholders across R&D.
**Organization**
+ Actively seek new ways of executing studies more efficiently to meet the needs of clinical development and encourage the function.
**Capability development**
+ In addition to the self-development, think about supporting the development of Clinical Operations staff by sharing knowledge and experience with them.
**_DIMENSIONS AND ASPECTS_**
**Technical/Functional (Line) Expertise**
+ Have sufficient knowledge of regulatory and compliance requirements and guidance for clinical development, assigned Therapeutic Areas (TAs), project governances, and working models and accurately assess the impact of these on the assigned TA and programs.
**Leadership**
+ Demonstrate ability to work across functions, regions, and cultures.
+ Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
+ Train and develop less experienced staff with an awareness of mid- to long-term function goals and clinical development.
**Interaction**
+ Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
+ Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
**Innovation**
+ Recommend and influence the ideal model and approach for meeting the program goals and TA operational strategies.
+ Challenge status quo and bring forward innovative solutions.
**Complexity**
+ Work in global ecosystem (internal and external) with a high degree of complexity.
**Decision-making and Autonomy**
+ Provide input and implement appropriate strategies with understanding the goals of the function and assigned TA.
**_EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:_**
+ Bachelor's Degree or international equivalent required, Life Sciences preferred.
+ Innovate and challenge peers and teams to think and work differently; Work independently, excel at solving issues without the need for support, but is effective at enlisting support for specific asks when necessary.
+ Participate and lead clinical operations in cross-functional initiatives and workstreams that affect clinical operations; Adapt ways of working to the function's current state and formulate strategic plans to work within the existing framework.
+ Capable of assessing gaps cross-functionally and can take a supportive role in leading changes that benefits the function as it related to clinical trial execution and study management.
+ Encourage and provide input, suggestions, and support for competency building within the organization.
+ Demonstrated excellence in study management, including scenario assessment, risk assessment and contingency planning.
+ Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills.
+ Talent development skills to enhance capabilities.
+ Experience of 10+ years in pharmaceutical industry and/or clinical research organization, including 7+ years of clinical study management/oversight.
+ Experience must include Phase 1, 2, 3 studies and global/international studies or programs.
+ Experience in more than one therapeutic area.
+ English (fluently in oral and written communication)
+ Local language (fluently, a native level)
**TRAVEL REQUIREMENTS:**
+ Requires approximately 5-20 % travel, including overnight and local/international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
**Locations**
IND - Bengaluru
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time