Senior Medical Data Reviewer

viewers, serves as the point of escalation for complex clinical data issues, and partners cross-functionally to drive inspection readiness, compliance, and operational excellence.

• Directly manage and develop Medical Data Reviewers, establishing clear expectations, accountability, and performance standards.

• Build team capability through hiring, coaching, training, and succession planning.

• Oversee Medical Data Review & Signal Detection ensuring high-quality review of adverse events, labs, vitals, ECGs, imaging, and key endpoints. Identify trends, outliers, protocol deviations, and emerging safety signals

• Serve as an escalation point for complex clinical data issues; providing expert clinical judgment to resolve complex or ambiguous data.

• Drive quality, compliance and risk management ensuring regulatory-ready documentation aligned with ICH-GCP, applying RBQM principles and leveraging KRIs/QTLs.

• Provide medical insight and strategic guidance to cross-functional partners to align data review outputs with study objectives and regulatory expectations.

• Strengthen and harmonize medical data review practices by advancing standardization, analytics adoption, and continuous process improvement.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate + 4 years
OR
Master's +8 years

Preferred Qualifications

• 5-7+ years in biopharma/CRO clinical research

• 2+ years people management experience

• Experience reviewing large, complex clinical datasets

• Strong understanding of RBQM and inspection readiness

• Proficiency in data analytics/visualization tools

• Strong clinical reasoning and communication skills

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.

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