Clinical Project Manager

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 escalate unresolved issues and identified risks to identified roles in the company as appropriate
• Create, manage and ensure tracking of study budget including revisions and perform final reconciliation at trial closeout

Qualifications & Personal Skills

• 6+ years of experience executing clinical programs in medical devices, clinical trials, Data Management or Clinical Monitoring
• Previous experience in a pharmaceutical, CRO or medical device company required
• Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485
• Fluent English, second language considered a plus