Global Clinical Trial Manager (Remote)

Amgen SA; Thousand Oaks, Northern (CA, KY); Hybrid; USD 138,000 - 164,000; Full time

Benefits offered by this job

Stock plan

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus

Job summary

Amgen is seeking a Local Trial Manager to lead country-level delivery of clinical studies. Responsibilities include data processing, SOP adherence, and coordinating with global teams to drive study progress. The role requires a Master’s degree in a related field and 3 years of trial-related experience.

The candidate will support regulatory submissions, audits, and CAPA development, while overseeing EDC, eTMF, CTMS, and IRT systems within a flexible work model including remote arrangements.

Qualifications

• Master’s degree in Drug Regulatory Affairs, Biology, Chemistry or related field and 3 years of experience in clinical trials.
• Experience applying ICH E6 (R2) GCP and FDA regulations in global trials.
• Experience managing trials from start-up to close-out with COPs, timelines and enrollment forecasting.
• Experience with CROs, central labs, imaging vendors and IRT providers.
• Familiarity with EDC, eTMF, CTMS, and IRT/IWRS/IVRS systems.
• Ability to coordinate cross-functional teams and ensure regulatory compliance.

Responsibilities

• Process and manage clinical data and documentation; ensure SOP compliance.
• Coordinate country-level strategies and study delivery with local teams.
• Support regulatory submissions and inspections; drive CAPA resolution.
• Lead or support cross-functional country operational plans and timelines.
• Monitor KPIs, time, cost, and quality metrics for trial progress.

Skills

GCP E6 (R2)

FDA regulations

Cross-functional lead

RBQM principles

Risk management

Data integrity (ALCOA+)

CTMS oversight

EDC systems (Medidata Rave)

eTMF systems (Veeva Vault TMF)

Regulatory submissions

Education

Master’s degree in Drug Regulatory Affairs, Biology, Chemistry or related field

Tools

Medidata Rave

Veeva Vault TMF

CTMS

IRT/IWRS/IVRS systems

Job description

Amgen is seeking a Local Trial Manager to lead country-level delivery of clinical studies. Responsibilities include data processing, SOP adherence, and coordinating with global teams to drive study progress. The role requires a Master’s degree in a related field and 3 years of trial-related experience.

The candidate will support regulatory submissions, audits, and CAPA development, while overseeing EDC, eTMF, CTMS, and IRT systems within a flexible work model including remote arrangements.