The Lead, Local Trial Manager is responsible for local management of clinical trials from start-up through database lock and closeout, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements
Job Summary
The Lead, Local Trial Manager is responsible for local management of clinical trials from start-up through database lock and closeout, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements.
This role involves coordinating local trial teams, managing budgets, overseeing site feasibility and selection, and ensuring timely reporting of adverse events to deliver high quality data on time and within budget.
The Lead, Local Trial Manager acts as a subject matter expert, mentors other trial managers, leads process improvements, and maintains strong relationships with internal and external stakeholders.
Matching Summary
The Lead, Local Trial Manager is responsible for local management of clinical trials from start-up through database lock and closeout, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements.
Skills & Requirements
Must-have
clinical trial management experience
Good Clinical Practice (GCP) compliance
clinical trial protocol adherence
local trial team leadership
clinical trial budget management
adverse event reporting
site feasibility and selection
Nice-to-have
process improvement leadership
training and mentoring skills
therapeutic knowledge development
stakeholder relationship management
cross-functional team collaboration
investigator meeting organization
risk and contingency planning
Key Requirements
minimum 4 years clinical trial management experience
more than 6 years clinical monitoring experience
knowledge of clinical research regulations
experience with Phase 1 – 3 studies
ability to manage local trial budgets
experience in vendor selection and contract negotiation