4 Nurse Administrator jobs in India

**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.

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
**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

·    Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks

·    Triage of Safety cases

·    Oversight of data discrepancy management

·    Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF

·    Responsible for compiling HoS content

·    Conduct the protocol amendment impact assessment and complete appropriate documentation

·    Manage migration and audit trail reports

·    Create slides for study-specific EDC investigator training

·    Generate all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.

·    Provide study specific training to data manager (DM)

·    Contribute to the Data Management Plan (DMP)

·    Request DTS creation and ensure DTS finalized and complete for any LSH loads

·    Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)

·    Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)

·    Manage global and study-specific data entry conventions

·    Facilitate versioning, including Unlock/audit trail review & Archival process

·    Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design

·    Timely communication with key stakeholders on issues and risks, including

o   Brings CDR, DWA, and SD together to discuss post-production changes when identified

·    Provide critical information to PL who will communicate with study team

·    Log any action issues into DS Hub and resolve outstanding issues assigned to DA

·    Mange assigned activities to meet milestone dates

·    Ask questions to get information needed to meet end goals

·    Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)

What you need

·    A Graduate/Post Graduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree

·    Minimum 2 years to 6 years of experience in clinical data management

·    Proactively communicate ownership of studies

·    Critical thinking to identify root causes and best solutions for data discrepancy management

·    Confidence to have tough conversations and make challenging decisions

·    Enables an environment of open and honest communication and critical thinking within DSS study team

·    Influence internal team to meet timelines by holding stakeholders accountable

·    Ability to work with different personalities to get the work done

·    Willingness to seek out information to accomplish goal

·    Proactive communication