Meditrial
Clinical Project Manager – Meditrial
Location:
Meditrial USA Inc., 866 United Nations Plaza, Suite 587, NY10017
Employment Type:
Full-time (In Office, Travel available on short notice)
Industry:
Lifesciences (Pharma, Medtech, Digital Health)
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 elevate unresolved issues and identified risks to appropriate roles in the company as needed
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+ years experience executing clinical programs in medical devices clinical trials, Data Management or Clinical Monitoring
Bachelor’s degree in Senscience; Master’s in a health‑related field is a plus
Fluent English; second language a plus
Previous experience in a pharmaceutical, CRO or medical device company required
Sound knowledge of GCP/CFR/ICH guidelines, ISO 9001, ISO 14155, ISO 13485
Seniority Level
Mid‑Senior level
Referrals increase your chances of interviewing at Meditrial by 2x.
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Meditrial USA Inc., 866 United Nations Plaza, Suite 587, NY10017
Employment Type:
Full-time (In Office, Travel available on short notice)
Industry:
Lifesciences (Pharma, Medtech, Digital Health)
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 elevate unresolved issues and identified risks to appropriate roles in the company as needed
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+ years experience executing clinical programs in medical devices clinical trials, Data Management or Clinical Monitoring
Bachelor’s degree in Senscience; Master’s in a health‑related field is a plus
Fluent English; second language a plus
Previous experience in a pharmaceutical, CRO or medical device company required
Sound knowledge of GCP/CFR/ICH guidelines, ISO 9001, ISO 14155, ISO 13485
Seniority Level
Mid‑Senior level
Referrals increase your chances of interviewing at Meditrial by 2x.
#J-18808-Ljbffr