Industry: Lifesciences Industry: Pharma, Medtech, Digital Health
Employment Type: Full-time
Job Functions: Clinical Affairs
Location: Meditrial USA Inc., 866 United Nations Plaza, Suite 587, NY10017
Workplace: In Office
Travel Available to travel on short notice
The role will lead and provide direction to 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 escalate 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
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Project Management and Information Technology
Industries
Hospitals and Health Care
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