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Job Description

JOIN AMGEN'S MISSION OF SERVING PATIENTS

At Amgen, our shared mission - to serve patients living with serious illnesses - drives all that we do. We combine science, technology, and the capabilities of our people to research, develop, and deliver innovative medicines. Our culture is collaborative, inclusive, and science-based, with a strong commitment to integrity, accountability, quality, and continuous learning.

ABOUT THE ROLE

The Senior Medical Data Reviewer is accountable and responsible for the study-level MDR workstream for assigned study or studies. The role defines and delivers the study review strategy, risk based fit for purpose medical monitoring inputs, integrates participant-level and aggregate findings, supplies scientific IDRP inputs, and provides clear medical-review insight to the Medical Monitoring Group and clinical study team.

ROLE DESCRIPTION

This is a study-responsible individual-contributor role. The Senior Medical Data Reviewer owns study MDR role and responsibilities from study start up to closure and delivery, including scientific IDRP inputs, risk-based review priorities, review quality, and milestone readiness. The Medical Monitor retains accountable medical oversight and medical decisions; the Clinical Scientist supports scientific integrity and study execution.

ROLES AND RESPONSIBILITIES

·   Define, maintain, and deliver the study MDR strategy from start-up through conduct, interim analyses, database lock, and closeout.

·   Translate protocol objectives, study risks, critical-to-quality factors, and emerging evidence into scientifically sound IDRP inputs, prioritized review activities, escalation pathways, programmed checks, and visualization needs.

·   Provide medical-interpretation inputs to a fit-for-purpose Medical Monitoring Plan within MDR scope as per IDRP; align proposed inputs with the Medical Monitor and Clinical Scientist.

·   Integrate participant-level and aggregate evidence, assess complex findings, and recommend proportionate follow-up or escalation.

·   Plan and coordinate MDR review cycles, define task-level expectations for assigned reviewers, and provide scientific and technical direction and peer mentoring. Partner with Associate Director, MDR on portfolio capacity and staffing decisions.

·   Responsible for overall quality of the assigned clinical trial/s in MDR perspective.

·   Represent MDR in Medical Monitoring Group, Clinical Study Group, integrated data review, risk review, study quality, interim-analysis, and database-lock readiness discussions.

·   Partner with the Medical Monitor, Clinical Scientist, Data Management, Safety, Clinical Operations, Biostatistics, and other study functions to resolve issues and maintain clear decision ownership.

·   Monitor review quality, timeliness, repeated findings, workload, and unresolved risks; adjust review intensity as the study risk profile changes.

·   Lead study-level use of ACT FAST/GDO Modernization workflows, Spotfire inputs and outputs, input to programmed checks, and approved digital capabilities; confirm that tools and outputs are validated for user testing and medically fit for purpose. Focus on use of evolving technology for efficient medical data review. Scientific and technical expertise are expected to apply on MDR operational execution.

·   Maintain inspection-ready MDR Documentation, evidence of review findings, decisions, escalations, and issue resolution.

·   Share scientific and technical knowledge, support training, mentoring, onboarding, and provide constructive review feedback to MDRs.

·   Responsible for participating in Audits and Inspections for the applicable study/s in scope, and contribute to CAPA.

STAKEHOLDER RELATIONSHIPS AND ROLE BOUNDARIES

Serves as the primary MDR contact for assigned studies and is an active member of the Medical Monitoring Group and study team. The Senior Medical Data Reviewer owns study MDR review strategy and delivery, supplies integrated medical-review findings, and escalate issues. The Medical Monitor retains accountable medical oversight and medical decisions as defined by the study governance model. The Clinical Scientist supports scientific and operational study execution within the assigned role. The Senior Medical Data Reviewer works with both roles to avoid duplication and ensure timely follow-up. Works within the study MDR strategy and collaborates with the Senior Medical Data Reviewer, Medical Monitor, Clinical Scientist, Data Management, Safety, Clinical Operations, Biostatistics, and other study-team members. The MDR provides medical data-review observations and interpretation for assigned review.

BASIC QUALIFICATIONS AND EXPERIENCE

·   MBBS and MD/Diploma fresher, 0-3 years of experience

·   MBBS from an MCI/NMC-recognized medical institution in India with 3-5 years of relevant experience

·   Relevant experience in clinical research, clinical development, medical data review, medical monitoring, pharmacovigilance, or comparable clinical-data interpretation.

·   Demonstrated ability to independently lead medical data review for a study or similarly complex clinical dataset.

·   Strong clinical judgment across participant-level and aggregate data, with evidence of timely risk identification and escalation.

·   Experience working with cross-functional study teams and delivering through critical milestones.

Final GCF placement reflects demonstrated clinical judgment, study accountability, complexity, and observable competencies; qualification or experience duration alone does not determine level.

PREFERRED QUALIFICATIONS AND EXPERIENCE

·   Experience in complex, global, early-development, registrational, or submission-critical trials.

·   Experience developing IDRP inputs, medical-review plans, Medical Monitoring Plan medical-interpretation inputs, programmed checks, or visualization requirements.

·   Working knowledge of RBQM, risk-based oversight, Spotfire, integrated review, and governed AI applications.

·   Experience providing technical guidance, facilitating discussions, and supporting colleague development without formal authority.

·   Knowledge of AI Literacy and its ethical applications in Clinical Development