Senior Clinical Project Lead - Trials & Compliance

Meditrial; New York (NY); On-site; USD 110,000 - 160,000; Full time

Job summary

Meditrial is seeking a Clinical Project Lead in New York to direct the Clinical Project Team and ensure timely, on-budget delivery of trials from protocol development through Clinical Study Report, with strict adherence to GCP and regulatory guidelines.

You will drive study timelines, coordinate specifications with clinical and regulatory teams, oversee monitoring activities, address enrollment risks, maintain TMF, and provide ongoing status updates to the CMO and sponsor teams.

Qualifications

• 6+ years of experience leading clinical programs in medical devices, data management, or monitoring.
• Bachelor’s degree in Lifescience; Master’s in a health-related field is a plus.
• Fluent English; another language is a plus.
• Experience in pharmaceutical, CRO, or medical device company required.
• Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485.

Responsibilities

• Define and drive study timelines and milestones.
• Coordinate the development of project specifications with clinical and regulatory teams and ensure quality control of deliverables.
• Contribute to regulatory documents and responses to Health Authorities.
• Plan, organize and lead Investigator meetings and CRA training & review related material.
• Oversee monitoring activities and conduct co-monitoring visits to ensure data quality.
• Provide study-specific direction to study team members.
• Address enrolment and retention issues to keep the study on track.
• Ensure proper study documentation is maintained and archived in the TMF.
• Resolve issues and identified risks to relevant roles in the company as appropriate.
• Provide regular study status updates to the CMO and Sponsor TCs.
• Create, manage and ensure tracking of study budget including revisions and final reconciliation.

Skills

Clinical Project Management

Clinical Trials

Regulatory Knowledge

Team Leadership

Education

Bachelor's degree in Lifescience

Master's in a health-related field

Job description

Meditrial is seeking a Clinical Project Lead in New York to direct the Clinical Project Team and ensure timely, on-budget delivery of trials from protocol development through Clinical Study Report, with strict adherence to GCP and regulatory guidelines.

You will drive study timelines, coordinate specifications with clinical and regulatory teams, oversee monitoring activities, address enrollment risks, maintain TMF, and provide ongoing status updates to the CMO and sponsor teams.