Amgen Hiring Central Monitor Manager, Data Acquisition Lead, Data Delivery Lead

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.

Amgen Hiring

Central Monitor Manager
Experience Range : 8 to 13 years
Areas of Expertise : Central Monitoring | Data Driven Monitoring | RBQM/RBM | Signal Detection | CluePoint/similar tools | DQLs | KRIs | QTLs | Threshold Reviews | Signal Mitigation
Job Description
• Lead proactive, data-driven risk surveillance across studies using central monitoring analytics to detect trends, anomalies, and emerging risks
• Translate complex statistical and operational findings into clear, actionable insights, recommending targeted interventions to study teams, CRAs, and functional leads
• Partner closely with Data Delivery Leads to implement, monitor, and continuously refine RBQM strategies (e.g., QTLs, KRIs, SRAs) across the study lifecycle
• Act as a subject matter expert in central monitoring tools and methodologies, driving consistent use and elevating team capability in signal detection and interpretation
• Document signal detection outputs, rationale, and recommended actions in an inspection-ready manner aligned with regulatory and internal governance expectations
• Facilitate feedback loops across sites, CRAs, and study teams to ensure issues are resolved and drive continuous process and quality improvement across the portfolio

Data Acquisition Lead
Experience Range : 8 to 13 years
Areas of Expertise : Data Acquisition | Non-CFR |DAS |ODC |Vendor Data |External Data Management | Rave |Veeva
Job Description
• In this vital role, you will lead the acquisition, integration, and quality management of non CRF (external/vendor) clinical trial data, ensuring it is timely, accurate, traceable, and fit for purpose to support study delivery, analytics, database lock, inspections, and regulatory compliance.
• Own the design, setup, and ongoing management of non CRF data (e.g., central labs, imaging, wearables, precision medicine), ensuring seamless integration, traceability, and compliant ingestion into EDC and other clinical data systems.
• Own, define, and maintain vendor data transfer specifications and agreements, aligned with protocol, study requirements, and downstream data needs; oversee test and production data transfers with suppliers.
• Ensure timely, accurate, and compliant ingestion of external datasets, proactively reviewing incoming data for quality, completeness, and consistency; resolve formatting, mapping, and data quality issues in collaboration with vendors and study teams.
• Lead reconciliation activities, initiating early and continuous reconciliation throughout the study lifecycle to prevent downstream delays and ensure ongoing data delivery and analysis readiness.
• Own issue and query resolution for external data, troubleshooting data transfer, integration, and consistency issues; escalate data risks, delays, quality concerns, or systemic issues to study teams and governance forums as needed.
• Partner closely with global and local cross functional study teams, the role requires experience managing external clinical trial data, strong knowledge of metadata standards, data review workflows, reconciliation methodologies, and EDC systems such as Rave and Veeva.
• Support database lock and inspection readiness, participating in governance and data review meetings, ensuring external data quality, traceability, and documentation standards are met.
• Drive process improvements, automation, and standardization initiatives to improve operational efficiency, scalability, data quality, and vendor integration performance.
• Possess strong operational and process-oriented mindset, effective problem-solving and risk management skills, strong communication, collaboration abilities and mentoring juniors.

Data Delivery Lead
Experience Range : 8 to 13 years
Areas of Expertise : • Monitor study data metrics (e.g., eCRF entry, Non-CRF data collection, query aging, reconciliation backlog, KRIs).
• Experience in management and oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)
Job Description
•• Serve as the single accountable leader for study-level data management, driving quality, delivery, and cross-functional alignment, locally and globally
• Lead development and execution of the Data Management Plan and Integrated Data Review Plan (IDRP) aligned to protocol and program strategy
• Drive database build, UAT, and go-live readiness in partnership with Database Design and Acquisition teams
• Oversee study conduct activities including data cleaning, query management, reconciliation, and database lock preparation, ensuring we are ‘delivery ready’ at all times
• Monitor study data metrics (e.g., eCRF entry, Non-CRF data collection, query aging, reconciliation backlog, KRIs) and proactively resolve issues to ensure on-time delivery
• Lead data deliverables, proactive in follow up, ensuring issue resolution and high-quality outputs

Work Location : HYDERABAD

Register by 29 May 2026
Hiring Drive Dates : 30 & 31 May 2026