About Us:
The Baim Institute for Clinical Research is a leading, non-profit academic research organization (ARO) that delivers insight, innovation, and leadership in today’s dynamic research environment. We collaborate with the world’s most highly respected researchers from renowned institutions to design and run clinical trials – and we are fiercely committed to finding creative solutions and delivering timely results that help advance health and quality of life around the world.
About the Position:
The Clinical Project Manager (CPM) assists in the planning and execution of clinical projects while adhering to budget, scope, and schedule. The CPM facilitates the coordinated interaction of all Baim Institute, sponsor and outside vendor actions related to the clinical trial and final deliverables. The CPM coordinates the activities of functional group that comprise the clinical department team include, but not limited to clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timeline completion. The CPM operates under general instruction and supervision on routine work with more detailed instructions and support on new assignments from the Project Strategic lead.
Primary Duties:
- Lead interdisciplinary team in a matrix organization
- Participate in the development and review of project budgets, manage ongoing functional team compliance with the project budget, report all budget deviations to the functional team members, department heads and accounting.
- Coordinate the development of project timelines and manage any changes thereto, including future timeline changes that may result from changes in scope, delays in schedule or resource constraints.
- Facilitate and maintain records of all internal and external communication relevant to assigned projects
- Effectively manages external resources;
- Coordinates all project and deliverable planning meetings;
- Assists with CRF/MOP and Project Plan development
- Attends investigator meetings
- Coordinates DSMBs including the selection of DSMB members, development of Charter, plans, schedules meetings and communicates report designs and timelines.
- Coordinates and documents data requests and facilitates communication of and completion of Contract Change Orders
- Tracks all study milestones and client deliverables
- Reviews all reports and client deliverables
- Maintain and develop client relationships
- Assist Sponsor Relations the presentation and support for new project proposals
- Generally, serve as the primary coordinator of communication among all internal, external and sponsor project team members
- Prepare all study related reports on project performance for both internal and external stakeholders;
- Present project performance at periodic project oversight meetings (Business Trial Strategy).
Requirements:
Education:
Required: BA/BS in the Life Sciences
Preferred: Project Management training
Years of Experience:
Required: 1-2 years of clinical trial management experience
Preferred: Clinical Trial experience in an ARO/ CRO environment