Clinical Project Manager

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

Industry: Lifesciences Industry: Pharma, Medtech, Digital Health
Employment Type: Full-time
Job Functions: Clinical Affairs
Location: Meditrial USA Inc., 866 United Nations Plaza, Suite 525, NY10017
Workplace: In Office
Travel Available to travel
The role will provide direction to the designated members of 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 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

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