Clinical Project Manager

GForce Life Sciences; Maple Grove (MN); On-site; USD 83,000 - 131,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Job summary

GForce Life Sciences is seeking a Consultant, Clinical Project Manager for medical devices. The role requires coordinating cross-functional teams, managing timelines and budgets, and supporting regulatory submissions.

The position is 4 onsite days per week with a 12-month contract, offering medical, dental, and vision benefits. The candidate should have a bachelor’s in health sciences, 2+ years PM experience in trials, and IDE experience.

Qualifications

• Bachelor's degree in Health Sciences or related field preferred.
• Minimum of 2 years clinical project management experience.
• Minimum of 3–5 years in clinical trials.
• IDE experience in regulatory submissions and handling

Responsibilities

• Facilitates communication between R&D, Regulatory Affairs, Sales and Marketing, Training, Senior Management and investigational sites by conducting team meetings and presenting updates.
• Manages site and study logistics including site list coordination and steering committee meetings.
• Manages clinical study timelines and budget using project management tools; selects providers and oversees vendor contracts.
• Identify resource needs and escalate constraints with management.
• Supports regulatory submissions and communications with Regulatory Affairs during the submission process.
• Contributes to development of clinical strategy and trial design in collaboration with departments.
• Provides input to protocol design, case report forms, and data management plans.
• Coordinates investigator and research coordinator meetings and study communications.
• Ensures compliance with study requirements and monitors protocol adherence.
• Supports study milestones: database locks, annual reports, publications and presentations.
• Sets quality and compliance goals for the trial and develops tools to improve performance.

Skills

Clinical project management

IDE experience

Education

Bachelor's degree in Health Sciences

Job description

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

• Bachelor's degree in Health Sciences field preferred
• Minimum of 2 years clinical project management experience
• Minimum of 3-5 years in clinical trials
• IDE experience

Term & Start

• 4 days onsite in either Maple Grove, MN, San Francisco Area, or Plano, TX
• 12-month contract (extension possible)
• Benefits included: Medical, Dental, Vision