Manager, Biospecimen Data Operations – Amgen (Hyderabad)
Amgen is hiring a Manager, Biospecimen Data Operations in Hyderabad, India for its Research division. This role focuses on managing biospecimen data operations, laboratory data systems, and study lifecycle management for clinical research programs. The position is responsible for overseeing biospecimen management processes, LIMS governance, laboratory data integrations, and regulatory compliance across clinical studies. You will collaborate with cross-functional teams including Clinical Operations, Data Management, laboratory partners, and IT teams to ensure accurate biospecimen tracking, data transfers, and study readiness through the entire research lifecycle. This role is ideal for professionals experienced in biopharmaceutical research operations, biospecimen management, clinical data systems, and laboratory information management systems (LIMS). The estimated salary for this role ranges from ₹28 LPA to ₹40 LPA depending on experience in biopharma R&D, clinical data operations, and team management.
Key Responsibilities
Manage end-to-end biospecimen operations across the study lifecycle, from study startup to database lock and archiving.
Oversee LIMS study setup, system integrations, and controlled data transfers for clinical research studies.
Ensure accurate sample tracking, reconciliation processes, discrepancy resolution, and shipment readiness.
Govern data release processes, database lock readiness, and data validation for study completion.
Maintain inspection readiness, audit trails, and CAPA integration within study operations.
Monitor study health, operational risks, and SLA compliance across multiple clinical studies.
Manage performance and governance of external vendors such as central labs, analytical labs, and biobank partners.
Drive adoption of automation tools, reporting systems, and process improvement initiatives.
Lead and mentor Senior Associates and data operations team members.
Collaborate with Clinical Operations, Data Management, labs, and IT teams to ensure smooth study execution.
Required Qualifications
Doctorate degree, OR Master’s degree with 3+ years experience, OR Bachelor’s degree with 5+ years experience in life sciences or related fields.
Strong experience in project management and supplier/vendor management.
Experience supporting research, clinical development, regulatory, safety, or scientific data operations.
Excellent communication skills and proficiency in English (written and verbal).
Strong proficiency with Microsoft Office tools such as Excel, Word, and PowerPoint.
Required Skills
Biospecimen Data Management
Clinical Research Operations
Laboratory Information Management Systems (LIMS)
Clinical Data Systems Integration
Vendor & Supplier Management
GCP / GxP Compliance
Data Governance & Database Lock Readiness
Project Management & Cross-Functional Collaboration
Salary
Approximate Salary: ₹28,00,000 – ₹40,00,000 per year (depending on experience in clinical research operations and biospecimen data management).
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Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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