Clinical Project Manager

GForce Life Sciences; Plano (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Job summary

GForce Life Sciences is seeking a results-oriented Clinical Project Manager to oversee multi-site trials and ensure on-time, within-budget delivery. You will coordinate cross-functional teams, manage timelines, and supervise regulatory submissions with oversight from Regulatory Affairs.

Responsibilities include protocol input, budget tracking, vendor management, and maintaining study quality. The role is 4 days onsite across Plano, Maple Grove, Santa Clara, Sylmar, CA and other sites, with a

Qualifications

• Minimum of 2 years clinical project management experience.
• Minimum of 3-5 years in clinical trials.
• IDE experience required.

Responsibilities

• Facilitates communication across R&D, Regulatory Affairs, Sales and Marketing, Training and Senior Management.
• Manages clinical study timelines and budget using project tools.
• Coordinates investigator and research coordinator meetings.
• Oversees compliance to study requirements and protocol.
• Coordinates activities for milestones like database locks and annual reports.

Skills

Clinical project management

Project coordination

Education

Bachelor's degree in Health Sciences

Tools

IDE experience

Job description

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