Biospecimen Data Operations Specialist
Biospecimen Data Operations Specialist
India - Hyderabad APLICAR AHORAABOUT 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 accurate and compliant study configuration in LIMS (products, categories, test plans, cohorts, schedules).
- Accountable for corresponding system configurations, dose schema alignment, and blinded data safeguards.
- Accountable for clinical data management interface setup, template selection, mapping integrity, and transfer readiness.
- Accountable for TrialBridge imports, quarantined record review, and discrepancy release.
- Accountable for inventory files and external biorepository interface initiation, monitoring, and shipment registration validation.
- Accountable for work order/test order creation and export template governance.
- Accountable for BSM Plan generation, version control, and DARS readiness inputs.
- Accountable for shipment readiness controls (no discrepant samples shipped).
- Accountable for study status transitions (Approved/Active/Completed) and end-of-study system closure.
- Accountable for documentation completeness across study lifecycle (data flow maps, contact lists, study-level logs).
Competencies
- Advanced LIMS configuration and system navigation skills.
- Strong understanding of specimen logistics, assay workflows, and lab interfaces.
- Technical fluency in file imports, mapping tables, template logic, and interface parameters.
- Precision documentation and audit-trail discipline.
- Structured troubleshooting across imports, shipments, and transfer failures.
- Knowledge of blinding controls and unblinding data handling.
- Multi-study prioritization and deadline management.
- Process ownership mindset with high execution reliability.
Qualification
- Master’s degree & 3 years of experience with a strong Knowledge of clinical trials OR
- Bachelor’s degree & 5 years of experience with a strong Knowledge of clinical trials.
- Prior experience in biospecimen operations and management in relation to clinical trials.
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 accommodation.