Clinical Project Manager

Consultant, Clinical Project Manager, Medical Devices Job Duties

• Facilitates communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to mgmt staff.
• Facilitates site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members.
• Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
• Identify resource needs and elevates / resolves resource constraints with mgmt.
• Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
• Facilitates the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback / direction.
• Provides input to protocol design, case report form design, data management plan, monitoring plan.
• Organizes Steering Committee meetings and communication; Coordinates investigator and research coordinator meetings.
• Oversees compliance to study requirements; Reviews compliance to protocol and elevates critical protocol deviations
• Works with Study Team to coordinate activities for all milestones; database locks, annual reports, presentation and publications
• Sets quality and compliance goals for the trial and monitors / manages compliance as part of clinical project management.
• Develops additional project management tools to improve clinical trial performance.

Requirements