Job Title: Manager, Biospecimen Data Operations
Company: Amgen
Location: Hyderabad, India
Job ID: R-238030
Work Location Type: On Site
Category: Research
Date Posted: Mar 05, 2026
Salary: ₹20,00,000 – ₹34,00,000 per year (Estimated)
Job Overview
The Manager, Biospecimen Data Operations leads the end-to-end operational delivery of biospecimen data management across the clinical study lifecycle. This role oversees study setup, biospecimen tracking, system integrations, and regulatory compliance processes. The manager ensures operational excellence by maintaining data integrity, managing vendor performance, and implementing standardized processes across studies. The position also plays a key role in driving automation, supporting inspection readiness, and leading a team responsible for biospecimen data operations within the India hub.
Key Responsibilities
Oversee end-to-end biospecimen operational delivery across the study lifecycle, from start-up through database lock and archival.
Govern LIMS study builds, ensuring integration integrity and controlled data transfers.
Maintain reconciliation standards, discrepancy resolution processes, and shipment readiness controls.
Oversee final results release governance, export validation to data management systems, and database lock readiness.
Ensure inspection readiness by maintaining audit trails, documentation completeness, and integration of CAPA or quality events into study operations.
Monitor Back Office Study Health metrics and establish escalation mechanisms for operational risks or SLA breaches.
Manage vendor performance including central laboratories, analytical labs, and biobank partners.
Lead adoption of automation initiatives, reporting validation standards, and change control lifecycle management.
Maintain governance of master data including tests, analytes, templates, mapping standards, and version control.
Manage and mentor Senior Associates, including workload prioritization, coaching, and performance development.
Oversee study builds, biospecimen management plans, system integrations, and study amendments.
Review and approve critical study deliverables such as BSM plans, mapping tables, and data flow documentation.
Serve as the primary escalation point for complex operational issues, data discrepancies, or system risks.
Partner with Clinical Operations, Data Management, laboratories, and IT teams to align study setup with protocol requirements.
Drive process standardization and quality control practices across multiple studies.
Identify operational gaps and lead process improvement initiatives.
Contribute to resource planning, forecasting, and prioritization for biospecimen data operations.
Required Skills and Competencies
Deep understanding of biospecimen lifecycle management, including blinded and unblinded data handling.
Strong knowledge of regulatory and compliance frameworks such as GCP and GxP.
Experience working with enterprise clinical systems such as LIMS, IRT, CDM, CLM, EBR, and reporting platforms.
Ability to influence cross-functional stakeholders including Data Management, Clinical Operations, laboratories, and IT teams.
Strong risk-based decision-making and escalation management skills.
Experience managing vendor relationships and overseeing performance metrics.
Process standardization and operational scaling expertise.
Strong executive communication and data-driven reporting skills.
Ability to lead digital transformation initiatives through automation and process optimization.
Qualifications
Minimum Requirements:
Doctorate degree, OR
Master’s degree with 3+ years of experience in supplier management or vendor leadership roles, OR
Bachelor’s degree with 5+ years of relevant experience, OR
Associate’s degree with 10+ years of relevant experience.
Additional Requirements:
Strong project management experience.
Fluency in written and spoken English.
Advanced proficiency in Microsoft Office tools including Excel, Word, and PowerPoint.
Technical expertise supporting Research, Development, Medical, Regulatory, Safety, or Knowledge Management functions.
Preferred Qualifications:
7+ years of experience in the life sciences industry, including 4+ years in biopharmaceutical R&D.
Experience managing R&D suppliers such as CROs, specialty labs, or imaging vendors.
Experience working within global, matrix-based organizations.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Reasonable accommodations will be provided to individuals with disabilities throughout the job application and interview process.
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