Clinical Study Project Manager

Job description

The Study Project Manager is ultimately accountable for the planning, execution, issue resolution, and communication / communication planning required for successful execution of each assigned clinical study or designated internal project. This includes holding planning meetings as needed with test facility or other personnel regarding study/project design, contract, timeline for prestudy activities (such as schedule, protocol, ethics committee, recruiting, documents, and data management), study/project execution, data analysis and clinical study report/other deliverables, and archiving.

During study/project execution, the Study Project Manager tracks project activities against the schedule, orchestrates all functions to identify and remove roadblocks, anticipates and resolves issues, and coordinates the participation of external resources. The Study Project Manager may conduct a post-mortem analysis. The Study Project Manager is the central point of communication to the study Sponsor or project requestor, and sends updates on a scheduled basis including information from all relevant functional areas Establish a standard project dashboard to show standard phases each study may go through in addition to visual status, timeline, and risk information.

This may include a version that can be shared with clients as a standard scheduled update. Establish a detailed project plan for each assigned study to coordinate and track execution with the appropriate functional teams.

• Run a weekly Project Management / Study Scheduling meeting to provide status updates, gather input for scheduling of new studies, escalate issues, and align on client communications / communication plans as needed
• Facilitate discussions for issue resolution by pulling together the needed experts and driving to consensus on the path forward, when required
• Communicate status or updates to project sponsors, or coordinate updates with the relevant Global Key Account Manager (GKAM) Suggest improvements to our study execution process based on observed inefficiencies or identified opportunities
• Complete training within required deadline
• Adhere to internal standards, policies, and procedures

Qualifications

• Bachelor’s degree (science, business, or project management preferred) 6-18 months clinical research experience or equivalent
• 2+ years of project management experience
• Ability to learn and use MS Project or other project management platform
• Strong understanding of clinic processes and flow, and ability to create study schedules that make good use of resources
• Ability to work with others to communicate requirements, build consensus, and overcome problems
• Excellent ability to establish priorities with minimal supervision and attention to detail