CLINICAL PROJECT MANAGER (REMOTE WEST COAST)

About the role

The Clinical Project Manager II is responsible for the planning, execution, and finalization of clinical trial projects according to timelines, budget, and scope in compliance with applicable rules and regulations. The Clinical Project Manager II will be the main liaison between project team members, vendors/contractors, and client/sponsor representatives. This role is generally assigned to low to high complexity trials. Depending on the details of the organization and/or the scope of work for a project, which is contracted to by the sponsor, a project manager may only oversee a selection of the duties below during an assigned project. A project manager may work in one or several projects at the same time.

Location: Remote, California. Employment type: Contract.

Responsibilities

• Major duties during the cost proposal process: Contributes to the initial planning during the cost proposal phase and may participate in the bid-defense meeting for clinical trials. Contributes to definition of project scope, goals, and deliverables in collaboration with sponsor, senior management, and other relevant stakeholders.
• Major Duties During The Project Set-up Phase: Acts as primary point of contact for considerations of the sponsor and ensures that sponsor interests are met (within the framework of the contractual and regulatory stipulations). Understands protocol, product specifications, and retains general knowledge of therapeutic area in sufficient detail to be able to advise and discuss with project team members and trial site personnel. Delegates work to assigned study team and monitors their progress to ensure deliverables are being met. Schedules internal and sponsor kick-off meetings with appropriate team members; ensuring that roles and responsibilities are clear and documented. Effectively communicates and continually manages project objectives and goals with team members and sponsor and other third parties, as appropriate. Develops Project Management Plan and any other study management plans. Determines needs for involvement of vendors and study equipment requirements. Participates in site selection including feasibility evaluation. Familiar with IP needs for project (IP packager/labeler, shipping, storage, return). Contributes to the generation, review, and approval of essential clinical study documents (protocol, IC