Clinical Data Management

10-15 years

Not Disclosed

Hyderabad

10 Sept. 15, 2025

Job Description

Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Vice President, Clinical Data Management

Location: India – Hyderabad (On-Site)
Job ID: R-222164
Category: Clinical
Posted Date: August 11, 2025

About Amgen

At Amgen, our mission is to serve patients living with serious illnesses. Since 1980, we have pioneered biotechnology in the fight against the world’s toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Diseases, we impact millions of patients each year.

Our culture is collaborative, innovative, and science-based. Join us to transform the lives of patients—and your career.

Position Overview

The Associate Vice President (AVP), Clinical Data Management is part of the Global Development Operations (GDO) leadership team and acts as a strategic partner to the R&D organization.

This role leads Amgen’s Clinical Data Management (CDM) function within GDO, ensuring excellence in data collection, processing, and analysis to support clinical development programs and regulatory submissions across all therapeutic areas and phases.

Key Responsibilities

Strategic Leadership

Define and execute the global data management strategy aligned with corporate and clinical development goals.
Represent CDM in executive discussions, regulatory interactions, and industry forums.
Drive innovation initiatives, including AI/ML adoption, automation, and advanced analytics.
Establish data governance policies, SOPs, and risk mitigation strategies.

Operational Excellence

Lead CDM operations across all clinical programs and phases.
Oversee regulatory submissions (NDA/BLA/MAA) and support advisory committee interactions.
Ensure audit readiness, compliance with GCP/ICH/FDA/EMA standards, and inspection preparedness.
Optimize outsourcing strategies, vendor partnerships, and technology platforms (EDC, CTMS, RWD/RWE).

Collaboration & Influence

Partner with Clinical Operations, Biostatistics, Regulatory Affairs, and R&D to ensure seamless data integration.
Influence internal leadership with data-driven insights.
Build relationships with CROs, vendors, regulatory authorities, and industry groups.

People & Change Leadership

Inspire and lead a global team, fostering a culture of compliance, innovation, and continuous improvement.
Drive organizational change and implement lean process improvements.
Promote data-driven decision-making across clinical programs.

Qualifications

Basic Qualifications

Bachelor’s or Master’s degree with 25+ years of data management experience.
10–15 years of managerial/leadership experience, managing teams, programs, or resources.

Preferred Qualifications

Extensive experience in clinical data management, regulatory compliance, and strategic leadership within pharma, biotech, or CRO.
Expertise in:
- GCP, ICH, FDA, EMA regulations
- CDISC standards (SDTM, ADaM)
- AI/ML-driven data solutions and digital health innovations
- Data governance & privacy regulations (GDPR, HIPAA)
Proven record in regulatory submissions (NDA/BLA/MAA).
Strong cross-functional collaboration and change management skills.
Experience with FSP management and technology implementations.
Familiarity with decentralized trials and digital health technologies.

Leadership Attributes at Amgen

Inspire: Build an inclusive and empowering environment.
Accelerate: Deliver with urgency and focus on progress over perfection.
Integrate: Leverage Amgen’s collective strengths to drive results.
Adapt: Lead through change with clarity and agility.

What You Can Expect from Us

A collaborative, inclusive, and ethical culture dedicated to advancing science.
Support for your professional growth, well-being, and work-life balance.
Competitive benefits and opportunities to thrive while serving patients.

Equal Opportunity Employer

Amgen provides equal employment opportunities to all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Reasonable accommodations are available upon request.

How to Apply

Click Apply Now to submit your application. Applications will be accepted until the position is filled.

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Clinical Data Management

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