Global Clinical Trial Lead – Local Trial Manager (Remote)

BioSpace; Thousand Oaks (CA); Hybrid; USD 138,000 - 164,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life insurance

Disability insurance

Annual bonus

Job summary

Amgen seeks a Local Trial Manager to lead country-level study delivery, data oversight, and regulatory activities. You will partner with global and local teams to ensure timely study progress, adherence to ICH GCP, and robust documentation using eTMF and CTMS systems.

The role requires the ability to manage vendors, monitor KPIs, and drive risk mitigation across trials, with potential telecommuting where appropriate.

Qualifications

• Master's degree or foreign equivalent in a related field and 3 years of clinical trial experience.
• Experience applying ICH E6 (R2) GCP and FDA regulations in global trials.
• Experience leading or supporting regulatory inspections and CAPA development.

Responsibilities

• Process and manage clinical data from study start-up through close-out.
• Coordinate cross-functional teams to ensure alignment with global program strategy.
• Support regulatory submissions and ethics/IRB communications.
• Oversee external vendors (CROs, labs, imaging, IRT) and monitor performance metrics.
• Ensure documentation completeness using eTMF and RBQM-based risk mitigation.

Skills

GCP compliance

Regulatory submissions

Risk assessment

Vendor management

Project coordination

Data integrity

Education

Master's degree in Drug Regulatory Affairs / Biology / Chemistry or related field

Tools

Medidata Rave

Veeva Vault TMF

CTMS

Job description

Amgen seeks a Local Trial Manager to lead country-level study delivery, data oversight, and regulatory activities. You will partner with global and local teams to ensure timely study progress, adherence to ICH GCP, and robust documentation using eTMF and CTMS systems.

The role requires the ability to manage vendors, monitor KPIs, and drive risk mitigation across trials, with potential telecommuting where appropriate.