Manager, Biospecimen Data Operations

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. 

Accountabilities

• Accountable for end-to-end biospecimen operational delivery across study lifecycle (start-up through database lock and archive).
• Accountable for LIMS study build governance, integration integrity, and controlled data transfers.
• Accountable for reconciliation rigor, discrepancy resolution standards, and shipment readiness controls.
• Accountable for final results release governance, data management export validation, and database lock readiness.
• Accountable for inspection readiness, audit trail completeness, and quality event/CAPA integration into study operations.
• Accountable for Back Office Study Health oversight, operational risk visibility, and SLA-based escalation model.
• Accountable for vendor performance governance (central labs, analytical labs, biobank partners).
• Accountable for automation adoption, reporting validation standards, and change control lifecycle oversight.
• Accountable for master data governance (tests, analytes, mapping standards, templates, version control).
• Accountable for talent management, workload prioritization (~multi-study portfolio), and capability scaling within India hub.
• Lead and manage Senior Associate(s), including workload prioritization, performance management, coaching, and development
• Ensure high-quality execution of study builds, sample management plans, integrations, and study amendments
• Oversee system imports, mappings, and sample inventory files schedules to ensure stable and compliant data flow
• Review and approve critical deliverables including BSM Plans, mapping tables, and study-level data flow documentation
• Serve as primary escalation point for complex study issues, data discrepancies, and system risks
• Partner with Clinical Operations, Data Management, Labs, and IT to align study setup with protocol and operational requirements
• Drive standardization of processes, documentation, and quality checks across studies
• Identify gaps, risks, and opportunities for system or process improvements and lead remediation efforts
• Support inspection readiness by ensuring documentation completeness and process adherence
• Contribute to resource planning, forecasting, and prioritization for data operations activities

Competencies

• Deep understanding of biospecimen lifecycle, blinded/unblinded data handling, and regulatory controls.
• Enterprise systems fluency (LIMS, IRT, CDM, CLM, EBR, reporting platforms).
• Strong governance orientation (GCP/GxP, Data base lock readiness, inspection preparedness).
• Cross-functional influence across Data Management, Clinical Ops, Labs, Biobank, IT.
• Risk-based decision making and structured escalation leadership.
• Vendor oversight and performance management capability.
• Operational scaling mindset with process standardization discipline.
• Executive-ready communication and data-driven storytelling.
• Change leadership across automation and digital enablement initiatives.

Qualifications

  The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements

•Doctorate degree

OR

•Master’s degree & 3 years of experience in supplier management at sponsor or supplier leadership at the vendor

OR

•Bachelor’s degree & 5 years of experience in supplier management at sponsor or supplier leadership at the vendor

OR

•Associate’s degree and 10 years of experience in supplier management at sponsor or supplier leadership at the vendor

AND

•Strong project management experience

•Fluency in English, both in written and oral communication

•Excellent user of Office Programs such as Excel, Word, Powerpoint

•Scientific or drug development technical expertise supporting Research, Development, Medical, Global Regulatory, Global Safety or Knowledge Management

Preferred Requirements

•7 years work experience in life sciences field, including 4 years of biopharmaceutical R&D experience

•Functional experience managing oversight of R&D suppliers (CROs, specialty labs, imaging suppliers, etc.)

•Experience working in a global, matrix organization

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.