Job Title: Lead Data Manager – Global Study Operations (GSO) – Data Management
Department: Clinical
Company: Amgen
Location: Hyderabad, India
Work Location Type: On Site
Date Posted: March 5, 2025
Application Deadline: Not specified
Job ID: R-209282
Job Summary:
Amgen is seeking a Lead Data Manager for its Global Study Operations (GSO) Data Management team. The role involves end-to-end data management support for clinical studies—ensuring accurate, high-quality data delivery, aligning with clinical timelines, and maintaining global regulatory standards. The successful candidate will lead study-level planning, execution, and vendor management while contributing to strategic development across multiple studies or programs.
Key Responsibilities:
Deliver clean and accurate clinical study data to support study planning.
Ensure adherence to timelines and quality standards in all data management activities.
Lead data management planning and execution at the study level.
Develop and maintain project-specific plans and documents.
Manage all phases of data management: study start-up, conduct, and close-out.
Oversee database development, maintenance, and change control.
Monitor and analyze data quality metrics and study status.
Maintain an up-to-date Trial Master File (TMF) and inspection readiness.
Serve as the primary DM point of contact for study teams.
Lead and manage vendor deliverables.
Provide inputs and review for cross-functional study documents.
Communicate and escalate risks or issues as needed.
Potentially supervise or mentor junior staff.
Basic Qualifications:
Master’s degree with 4–6 years of experience in Data Management OR
Bachelor’s degree with 6–8 years of experience in Data Management OR
Diploma with 10–12 years of experience in Data Management
Must-Have Skills:
In-depth knowledge of data management processes
Strong project planning and execution skills
Understanding of clinical trial processes and drug development
Knowledge of Good Clinical Practice (GCP)
Good-to-Have Skills:
Experience across multiple therapeutic areas
Exposure to quality management and regulatory filings
Experience with vendor oversight
Familiarity with regulatory inspections
Soft Skills:
Strong teamwork and communication
Detail-oriented and delivery-focused
Good problem-solving and initiative
Effective relationship-building and leadership
Strategic thinking and prioritization skills
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer and considers all qualified applicants without regard to race, religion, gender, disability, veteran status, or other protected characteristics. Reasonable accommodations will be provided for individuals with disabilities throughout the recruitment process.
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