Job Summary
A leading pharmaceutical company is seeking a Remote Trial Master Files Management Associate Director.
Core Responsibilities Include:
- Overseeing and managing operational strategy
- Establishing, implementing, and enforcing the quality oversight management
- Overseeing distribution of status updates to senior leadership and other teams
Applicants must meet the following qualifications:
- 10+ years of progressive responsibility/experience in a pharmaceutical, biotechnology or related environment
- Minimum of 2+ years of demonstrated leadership ability and experience managing TMF teams
- Proficiency with eTMF technology including
- Experience with the Drug Information Association (DIA) Trial Master File Reference model
- Demonstrated understanding of the clinical drug development process and clinical trial methodology
- Demonstrated current knowledge of ICH, GCP and other regulatory guidance