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Director, Clinical Data Management

8-10 years
Not Disclosed
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

Director, Clinical Data Management

Location: India – Hyderabad
Work Location Type: On-Site
Job ID: R-223794
Date Posted: August 29, 2025
Category: Clinical Development


About the Role

Amgen’s Global Clinical Data Management team is seeking an experienced Director, Clinical Data Management to lead and inspire a high-performing team. This role is pivotal in optimizing and delivering an industry-leading clinical evidence platform, enabling the development of innovative medicines for patients with unmet medical needs.

The Director will provide strategic leadership and operational oversight of Data Management (DM) activities, ensuring excellence and consistency in clinical trial execution. You will also play a key role as part of the Global Study Operations (GSO) leadership team, driving innovation, process improvements, and strong cross-functional collaborations.


Key Responsibilities

Leadership & Strategy

  • Lead and manage Data Management teams within a defined operational business unit.

  • Set and drive the vision and strategy for DM as a member of the DM and GSO leadership team.

  • Define and implement annual functional goals, objectives, and long-term strategies aligned with organizational priorities.

Team & Resource Management

  • Recruit, mentor, and develop staff, fostering a culture of high performance.

  • Oversee global resource planning, assignments, and training.

  • Ensure compliance of staff with all DM processes, SOPs, and regulatory requirements.

Operational Excellence

  • Develop, review, and implement global DM policies, SOPs, and standards.

  • Oversee delivery of study data and submission activities for assigned products.

  • Ensure DM systems and processes align with business and regulatory requirements.

  • Govern and manage external Functional Service Providers (FSPs) and vendors.

  • Define and maintain Service Level Agreements (SLAs) and Key Performance Indicators (KPIs), ensuring oversight of quality and CAPA management.

Governance & Collaboration

  • Actively contribute to GSO leadership and cross-functional working groups.

  • Manage vendor strategies, contract negotiations, and relationships.

  • Provide visibility into FSP performance and ensure business objectives are met.

  • Support audits, inspections, and regulatory submissions.


Basic Qualifications

  • 18–23 years of data management experience.


Preferred Qualifications

  • Master’s degree (or equivalent) in Life Sciences, Computer Science, Business Administration, or related discipline.

  • 10+ years of extensive data management experience in the pharmaceutical or biotech industry.

  • 8+ years of leadership experience in rare disease therapeutic areas.

  • Proven experience managing global organizations and external vendors (CROs, labs, imaging vendors, etc.).

  • 8+ years of managerial experience leading teams, projects, or programs.

  • Demonstrated ability to drive operational excellence with strategic and innovative thinking.

  • Strong relationship-building skills with proven ability to influence stakeholders and impact business outcomes.

  • Project management expertise with experience in a global, matrixed environment.

  • Excellent organizational, interpersonal, and problem-solving skills.

  • Ability to anticipate challenges and implement effective solutions.


Why Join Us

At Amgen, you will be part of a fast-paced, high-impact global team of ~50 professionals dedicated to compliance, quality, and innovation. As a Director, you’ll help shape the future of clinical data management and contribute to delivering life-changing therapies to patients worldwide.