Director, Clinical Data Management

18 to 23 years years

Not Disclosed

10 Sept. 2, 2025

Job Description

Job Type: Full Time Education: Master’s degree or equivalent in life sciences, computer science, business, or related field 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:

Director, Clinical Data Management

🏢 Company:

Amgen

📍 Location:

Hyderabad, India
(Work Type: On-Site)

📅 Date Posted:

August 29, 2025

🔢 Job ID:

R-223794

🧪 Job Category:

Clinical Development

🌍 Work Location Type:

On Site

🧬 About Amgen:

Amgen is a global biotechnology leader focused on discovering, developing, manufacturing, and delivering innovative medicines to serve patients with serious illnesses. With a culture that is collaborative, science-based, and innovation-driven, Amgen is committed to making a meaningful impact on global health.

Learn more: www.amgen.com

💼 Role Overview:

The Director, Clinical Data Management plays a critical leadership role in the Global Clinical Data Management (GCDM) team at Amgen. The role is accountable for overseeing clinical data operations and leading a high-performing internal DM team, while ensuring strategic alignment with Functional Service Providers (FSPs) and broader Global Study Operations (GSO) objectives.

This role will drive operational excellence, compliance, and innovation within clinical trial data management while contributing to the vision of delivering an industry-leading clinical evidence platform.

🛠️ Key Responsibilities:

⚙️ Leadership & Strategy:

Lead a distinct operational unit within Data Management (e.g., by therapy or product area)
Set the vision, strategy, and direction for the DM group
Be an active member of the GSO & DM Leadership Teams
Contribute to strategic planning and innovation for global clinical data practices

👥 People & Team Management:

Recruit, manage, and develop internal DM staff
Lead team performance evaluations, coaching, and career development
Ensure adequate training and capability-building within the team

🔄 Operations & Delivery Oversight:

Oversee data management processes across clinical programs to ensure regulatory compliance and data quality
Ensure all study deliverables and submission activities within the group are met
Monitor and ensure status information on DM activities is accurate and acted upon

🤝 Vendor and FSP Oversight:

Manage and govern FSP relationships; define SLAs and KPIs
Provide visibility into performance and accountability for FSP partners
Ensure alignment of vendor activities with Amgen priorities

🧾 Policy & Compliance:

Develop and maintain SOPs, policies, and global data standards
Respond to internal and external audits and inspection findings
Sponsor or lead cross-functional working groups and quality initiatives

💰 Resource & Budget Management:

Oversee global resource planning, budgeting, and vendor contracts
Ensure adequate staffing and resource allocation across global programs

🧑‍💼 What We Expect of You:

✅ Basic Qualifications:

18 to 23 years of experience in clinical data management

🌟 Preferred Qualifications:

Master’s degree or equivalent in life sciences, computer science, business, or related field
10+ years in data management within pharmaceutical or biotech industries
8+ years in rare disease therapeutic areas in a leadership role
Experience managing or working within global teams and matrix organizations
Experience with clinical research suppliers (CROs, labs, imaging vendors, etc.)
8+ years of managerial/leadership experience with team or resource oversight
Demonstrated strategic thinking and operational excellence
Expertise in project management, stakeholder engagement, and business impact delivery
Ability to work collaboratively across cross-functional global teams
Experience in regulatory compliance, audits, vendor governance, and SOP development
Strong interpersonal, problem-solving, and communication skills

🔑 Core Competencies:

Strategic and innovative thinking
Vendor and FSP oversight
Leadership in global and matrix settings
Cross-functional influence and decision-making
Regulatory and data compliance
Budgeting and resource planning
SOP/policy development
Clinical systems and analytics

📩 Application Process:

Interested candidates can Apply Now via Amgen Careers or the provided application portal.

💡 Equal Opportunity Employer:

Amgen is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Reasonable accommodations are available upon request for individuals with disabilities.

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Director, Clinical Data Management

Job Description

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