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Associate Vice President (Avp), Clinical Data Management

25+ years years
Not Disclosed
10 Sept. 2, 2025
Job Description
Job Type: Full Time Education: Bachelor’s or Master’s Degree 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

Job Title:

Associate Vice President (AVP), Clinical Data Management


🏢 Company:

Amgen


📍 Location:

Hyderabad, India
(On-site role)


📅 Date Posted:

August 11, 2025


🔢 Job ID:

R-222164


🧪 Job Category:

Clinical


🌍 Work Location Type:

On Site


🎯 About Amgen:

Since 1980, Amgen has been a pioneer in biotechnology, focused on serving patients suffering from serious illnesses. The company operates in four key therapeutic areas:

  • Oncology

  • Inflammation

  • General Medicine

  • Rare Disease

With millions of patients impacted annually, Amgen’s mission is to improve lives through innovative medicines and groundbreaking science.

🌐 Website: www.amgen.com


💼 Position Summary:

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

This leader is responsible for the strategic direction, leadership, and operational oversight of global data management processes across all clinical development programs and therapeutic areas.


🛠️ Key Responsibilities:

  • Strategy & Leadership:

    • Develop and drive global CDM strategy aligned with Amgen’s clinical and corporate objectives.

    • Lead innovation in data management including AI/ML technologies and digital health tools.

  • Operations & Execution:

    • Ensure high-quality clinical data collection, processing, and analysis for regulatory submissions.

    • Oversee CDM SOPs, best practices, data governance, and quality standards.

  • Collaboration & Representation:

    • Act as the CDM lead during regulatory inspections and audits.

    • Represent CDM in executive leadership meetings, regulatory bodies, and industry forums.

  • Risk Management & Compliance:

    • Implement risk mitigation strategies and ensure compliance with global standards (GCP, ICH, FDA, EMA).

    • Ensure readiness for inspections and drive a culture of continuous improvement.

  • Resource & Vendor Management:

    • Optimize staffing, outsourcing strategies (e.g., FSP), and technology investments.

    • Manage CROs, vendors, and cross-functional partnerships (Regulatory, Biostatistics, Clinical Ops).


📚 Basic Qualifications:

  • Bachelor’s or Master’s Degree

  • 25+ years of experience in Clinical Data Management

  • 10 to 15 years of leadership or managerial experience


🌟 Preferred Qualifications:

  • Deep knowledge of:

    • GCP, ICH, CDISC, SDTM, ADaM, FDA/EMA regulations

    • Data governance, audit readiness, and regulatory compliance

  • Expertise in:

    • AI/ML, automation, digital trials, decentralized models

    • Advanced analytics & clinical data standards

  • Proven leadership in:

    • Large global teams, CRO/vendor partnerships, cross-functional collaboration

    • Organizational change, process optimization, and lean implementation

  • Experience in:

    • Regulatory submissions (NDA/BLA/MAA)

    • Technology platforms (EDC, CTMS, RWD/RWE)


💡 Leadership Attributes:

  • Inspire: Build a connected, inclusive, and high-performing team culture

  • Accelerate: Act with urgency and drive results with focus on patients

  • Integrate: Collaborate across functions to maximize impact

  • Adapt: Embrace change and provide clarity in complex environments


🎁 What You Can Expect at Amgen:

  • A collaborative, science-driven culture

  • Opportunities to make a lasting impact on global health

  • Inclusive work environment with competitive benefits

  • Commitment to professional growth and well-being


Equal Opportunity Employer:

Amgen is committed to diversity, equity, and inclusion. Reasonable accommodations will be provided for individuals with disabilities during the application, interview, and employment process.


📩 Application Process:

  • No deadline; applications accepted until the position is filled

  • Apply through Amgen Careers