POSITION TITLE: Clinical Project Manager REPORTING TO: VP
DEPARTMENT: Medical Devices DIRECT REPORTS: None
SUMMARY OF POSITION:
The goal of a CPM is to drive projects utilizing best practices in order to ensure budgets, timelines and clinical trial requirements are met on behalf of the client. The role requires active involvement to meet schedules, resolve problems or conflicts, and entails frequent interaction with staff, clients, peer managers and senior management.
Manages cross functional project teams derived from the groups within clinical development to deliver a high quality clinical trial(s).
Drives all aspects of the project management process from initiation, planning, execution, control and closure.
Reviews protocol, source documents and CRFs and tracks them to completion.
Responsible for creating and maintaining project timelines for each project, and uses these timelines to track and manage a project’s progress.
Responsible for creating Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each study.
Responsible for periodic (weekly, or as needed) clinical trial team meetings.
Reviews study metrics for performance and quality with the team and management.
Ensures review of Clinical Trial Master File for completeness.
The CPM has the responsibility manage the study conduct to completion in compliance with all regulations and SOPs.
The CPM acts as an operational focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, regulatory), coordinating these different groups in a matrix environment to drive and complete clinical programs.
Manage and coordinate all vendors involved in the clinical trials, e.g. central labs, reading centers
Prepares reports (financial, project, etc.) for management on program status and issues.
REQUIRED SKILLS AND ATTRIBUTES:
Highly effective organizational and communication skills.
Demonstrated knowledge of GCP and Regulatory requirements.
Understanding of multi-center device trials a plus.
Demonstrated leadership skills and the ability to solve problems proactively.
Travel of up to 20% is required (mainly domestic, overnight)
Proficiency with Excel, PowerPoint and vendor management
Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term company objectives.
BS or MS in a Life Science, 2+ years of industry clinical project management experience, 5+ years of industry clinical experience.