Clinical Project Manager

GForce Life Sciences; Maple Grove (MN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Job summary

GForce Life Sciences seeks a Consultant, Clinical Project Manager for Medical Devices to coordinate across R&D, Regulatory Affairs, Sales and Marketing, Training and senior management. You will manage timelines, budgets, vendor contracts and ensure adherence to protocol and regulatory requirements.

You will facilitate site selection, assist with trial design, and organize Steering Committee meetings. The role is 4 days onsite in Maple Grove, MN, SF Bay Area, or Plano, TX, on a 12-month contract

Qualifications

• Bachelor's degree preferred in Health Sciences.
• Minimum 2 years clinical project management experience.
• Minimum 3-5 years in clinical trials.
• IDE experience required.
• Medical device and cardiovascular device experience preferred.

Responsibilities

• Facilitates communication among R&D, Regulatory Affairs, Sales and Marketing, Training and senior management.
• Manages clinical study timelines and budget using PM tools; selects providers and manages vendor contracts.
• Identifies resource needs and resolves constraints with management.
• Supports regulatory submissions and communications with Regulatory Affairs.
• Develops clinical strategy and trial design with cross-functional input.
• Contributes to protocol design, CRFs, data management and monitoring plans.
• Organizes Steering Committee and investigator meetings; coordinates meetings.
• Oversees study compliance and escalates protocol deviations.
• Coordinates activities for milestones, database locks, annual reports, presentations and publications.
• Sets quality and compliance goals and develops tools to improve trial performance.

Skills

2+ years PM experience

3-5 years clinical trials

IDE experience

Medical device experience

Cardiovascular device 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
• Medical device experience preferred
• Cardiovascular device experience preferred

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