Local Trial Manager — Remote

Amgen Inc.; Thousand Oaks (CA); Remote; USD 138,000 - 164,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Bonus eligibility

Job summary

Amgen is seeking a Local Trial Manager to drive country-level study delivery within a global program. You will manage cross-functional teams, oversee data processes, and support regulatory submissions and inspections.

The role emphasizes GCP compliance, risk management, vendor coordination, and the use of EDC/eTMF/CTMS systems to ensure study success across the country. A Master’s degree and 3+ years in clinical trials are expected.

Qualifications

• Master’s degree in a science or regulatory field with relevant trial experience.
• Proven ability to manage global clinical trials and regulatory submissions.
• Experience with EDC, eTMF, and CTMS systems is required.

Responsibilities

• Process and oversee clinical data from studies and ensure SOP compliance.
• Lead country-level study delivery and cross-functional team coordination.
• Support regulatory submissions and inspections with CAPA resolution.
• Monitor trial progress, timelines, budgets, and KPIs.

Skills

ICH GCP

FDA regs

Global trials

COP planning

CTMS mgmt

EDC systems

eTMF systems

IRB submissions

RBQM

Vendor mgmt

KPI tracking

Audit readiness

IRT systems

Documentation control

Education

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

Tools

Medidata Rave

Veeva Vault TMF

CTMS

Job description

Amgen is seeking a Local Trial Manager to drive country-level study delivery within a global program. You will manage cross-functional teams, oversee data processes, and support regulatory submissions and inspections.

The role emphasizes GCP compliance, risk management, vendor coordination, and the use of EDC/eTMF/CTMS systems to ensure study success across the country. A Master’s degree and 3+ years in clinical trials are expected.