Clinical Project Manager

Industry: Lifesciences Industry: Pharma, Medtech, Digital Health

Employment Type: Full-time

Job Functions: Clinical Affairs

Workplace: Minneapolis

Travel Available to travel on short notice

The role will lead and provide direction to the Clinical Project Team to ensure all trial outputs (from protocol development to Clinical Study Report) are delivered on time, within budget, and with high quality, in adherence to internal SOPs, GCP and applicable regulatory guidelines. The role will be responsible for project delivery of clinical studies to meet contractual requirements focusing on productivity and sponsor satisfaction. The position will be ultimately accountable for the management of their own study leveraging his/her expertise to drive excellence and strategic support to clients.

Responsibilities

• Define and drive study timelines and milestones
• Coordinate the development of project specifications in collaboration with clinical and regulatory teams and ensure appropriate quality control of deliverables
• Contribute to the development of regulatory documents, responses to Health Authorities, EC/IRB and DSMB questions
• Plan, organize and lead Investigator meetings and CRA training & review related material
• Oversee monitoring activities and conduct co-monitoring visits (if applicable) to ensure data quality
• Provide study-specific direction to study team members
• Address enrolment and retention issues, identify and implement actions to keep the study on track
• Ensure proper study documentation is maintained and archived in the TMF
• Resolve issues in a proactive and timely fashion and escape unresolved issues and identified risks to identified roles in the company as appropriate
• Provide regular study status updates to the CMO and during Sponsor TCs
• Create, manage and ensure tracking of study budget including revisions and perform final reconciliation at trial closeout

Qualifications & Personal Skills

• 6+ year experience executing clinical programs in medical devices clinical trials, Data Management or Clinical Monitoring
• Education: Bachelor’s degree in Lifescience, Master in a health-related field is a plus
• Languages: fluent English, second language is considered a plus
• Previous experience in a pharmaceutical, CRO or medical device company required
• Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485