Lead Clinical Project Manager, Medical Devices

Laborie; Minnetonka (MN); Vor Ort; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Paid time off

Medical, Dental, Vision benefits

Health Savings Account with company-fn

401k with company match

Parental leave

Zusammenfassung

Laborie is seeking a Clinical Project Manager to oversee all aspects of Clinical Trial Team activities for assigned projects. You will manage timelines, budgets, resources, and vendors, coordinating with the Clinical Program Manager and CTO to meet regulatory requirements.

The role requires extensive clinical operations experience in the medical device field, strong English communication, and proficiency with ICH/GCP and TMF processes. Collaboration and leadership are essential.

Qualifikationen

• Bachelor's degree in Life Sciences required; advanced degree preferred.
• 8+ years of clinical operations experience in medical devices or CRO industry.
• Minimum 2 years of clinical PM experience at sponsor or CRO.
• Experience with regulatory medical writing (CER, PMS, PMCF, PSUR).
• Fluent English with strong written and verbal communication; proficient in MS Office.

Aufgaben

• Manage trial timelines, budgets, resources, and vendors at the project level.
• Provide trial progress updates to Clinical Program Manager and CTO; oversee vendor selection and budgets.
• Lead sponsor startup activities: K.O. meeting, TMF setup, site and vendor agreements.
• Ensure SOP-compliant, ICH/GCP-regulated trial plans and TMF filing and maintenance.
• Chair meetings, distribute minutes, monitor vendor deliverables, and address quality issues.
• Review and approve vendor invoices to ensure timely investigator payments.
• Support TMF filing, maintenance, and archival procedures across trials.
• Assist Clinical Research Team in trial conduct.

Kenntnisse

English fluency

Communication skills

MS Office

Ausbildung

Bachelor's degree in Life Sciences

Master's or Doctoral degree preferred

Tools

Laboratory/Clinical software

Jobbeschreibung

Laborie is seeking a Clinical Project Manager to oversee all aspects of Clinical Trial Team activities for assigned projects. You will manage timelines, budgets, resources, and vendors, coordinating with the Clinical Program Manager and CTO to meet regulatory requirements.

The role requires extensive clinical operations experience in the medical device field, strong English communication, and proficiency with ICH/GCP and TMF processes. Collaboration and leadership are essential.