Senior Clinical Project Lead – Medical Devices Trials

Meditrial; Minneapolis (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

Meditrial in Minneapolis seeks a Clinical Project Lead to direct study delivery from protocol development to Clinical Study Report. You will manage timelines, budgets, and cross-functional coordination with clinical, regulatory, and quality teams to ensure trials meet GCP standards and sponsor expectations.

The role requires a strong background in medical device or pharma trials, excellent leadership, and the ability to drive studies to on-time completion in a fast-paced environment.

Qualifications

• 6+ years of experience executing clinical programs in medical devices clinical trials, Data Management or Clinical Monitoring
• Bachelor’s degree in Lifescience; Master’s in a health-related field is a plus
• Fluent English; second language a plus
• Experience in pharmaceutical, CRO or medical device company required
• Solid knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485

Responsibilities

• Define and drive study timelines and milestones
• Coordinate development of project specifications with clinical and regulatory teams and ensure quality control of deliverables
• Contribute to regulatory documents and responses to Health Authorities, EC/IRB and DSMB questions
• Plan, organize and lead Investigator meetings and CRA training and review related material
• Oversee monitoring activities and co-monitoring visits to ensure data quality
• Provide study-specific direction to study team members
• Address enrollment and retention issues to keep the study on track
• Ensure proper study documentation is maintained and archived in the TMF
• Resolve issues proactively and escalate risks as appropriate
• Provide regular study status updates to the CMO and Sponsor TCs
• Create, manage and track study budget including revisions and closeout

Skills

Clinical program mgmt

Regulatory knowledge

GCP/ICH knowledge

Budget management

Team leadership

Communication

Data management

Education

Bachelor’s degree Lifescience

Master degree in health-related field

Job description

Meditrial in Minneapolis seeks a Clinical Project Lead to direct study delivery from protocol development to Clinical Study Report. You will manage timelines, budgets, and cross-functional coordination with clinical, regulatory, and quality teams to ensure trials meet GCP standards and sponsor expectations.

The role requires a strong background in medical device or pharma trials, excellent leadership, and the ability to drive studies to on-time completion in a fast-paced environment.