Project Manager - Early Phase

Provides overall leadership of Early Phase clinical trials or programs.

Owns the sponsor relationship, provides a central point of study contact, and ensures proactive communication with sponsors and internal groups

Ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy.

Manages study start-up activities, defines and plans site selection strategy, manage submission, reviews project contracts and budgets, and sets up project team and vendors

Identifies potential project risks, implements contingency plans, and keeps clients informed about risks and contingencies

Leads administrative closeout procedures, ensures project documentation is archived, and conducts end-of-study meetings to document lessons learned

Accountable for the financial aspects of project(s) including input into revenue recognition, milestone payments, and monthly pass-through invoices.

Understands and ensures compliance with SOPs, contract terms, system requirements and metrics.

Oversees PM Assistants to assure development of the project plan, team lists, and maintenance of central files /regulatory files.