Clinical Project Manager

GForce Life Sciences; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision

Job summary

GForce Life Sciences is seeking a Consultant, Clinical Project Manager for a 12-month contract focused on medical devices. The role requires coordinating R&D, Regulatory Affairs, and clinical teams, and leading site selection and investigator coordination while ensuring budget adherence.

The candidate should have IDE experience and 3–5 years in clinical trials, with at least 2 years in clinical project management. 4 onsite locations include Maple Grove, MN and other U.S. sites. Benefits included.

Qualifications

• 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.

Responsibilities

• Coordinate and manage clinical study timelines and budgets.
• Facilitate regulatory submissions and communications with Regulatory Affairs.
• Lead site/investigator meetings and manage site list coordination.
• Identify resource needs and resolve constraints with mgmt.
• Support protocol design and data management planning with teams.
• Oversee study compliance and review protocol adherence.
• Coordinate milestones, database locks, annual reports and publications.
• Develop project management tools to improve trial performance.

Skills

Clinical project management

Regulatory submissions

Cross-functional coordination

Vendor management

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, Santa Clara, CA, Plano, TX, or Sylmar, CA
• 12-month contract (extension possible)
• Start ASAP
• Benefits included: Medical, Dental, Vision