Clinical Program Lead, Medical Devices Trials

Meditrial; New York (NY); On-site; USD 140,000 - 190,000; Full time

Job summary

Meditrial USA Inc. in New York is seeking a Senior Clinical Project Lead to direct clinical study programs from protocol development through to final study reports. The role is office-based with travel as needed.

You will manage timelines, budgets and cross-functional teams, ensuring GCP compliance, quality control of deliverables, and regulatory submissions to health authorities while driving sponsor satisfaction.

Qualifications

• 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

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 resolve 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

Skills

Clinical project management

GCP/CFR/ICH knowledge

Team coordination

Education

Bachelor’s degree in Lifescience

Master’s degree in health-related field

Job description

Meditrial USA Inc. in New York is seeking a Senior Clinical Project Lead to direct clinical study programs from protocol development through to final study reports. The role is office-based with travel as needed.

You will manage timelines, budgets and cross-functional teams, ensuring GCP compliance, quality control of deliverables, and regulatory submissions to health authorities while driving sponsor satisfaction.