Clinical & Regulatory Affairs Specialist
Meditrial, New York, NY, United States
Overview
Industry: Lifescience, Pharma, Medtech, Digital Health
Employment Type: Full-time
Job Functions: Clinical Affairs
Location: Meditrial USA, 866 United Nations Plaza, New York, USA
Workplace: Office-based, availability to travel
Responsibilities
Proactively manage project-level operations, including trial timeline, budget, resources with consideration of quality standards and risk mitigation.
Provide efficient and effective updates on trial progress to the Medical Director as requested.
Lead sponsor study start‑up processes, conduct trial kick‑off meetings, set up trial master file (TMF), site selection, and finalize site and vendor Clinical Trial Agreements (CTAs) and budgets.
Ensure effective project plans for each trial, coordinating with the Clinical Trial Team on priorities, SOPs, GCP guidelines, and regulatory requirements.
Attend study update meetings, ensure minutes are completed, distributed, and filed in the TMF timely; review and approve site visit reports, follow‑up on site‑specific issues.
Monitor quality of deliverables, address quality issues with team members, and identify opportunities to improve training, execution, and quality control.
Qualifications
Education: Bachelor’s degree in Life Sciences; Master in health‑related field is a plus.
Languages: Proficiency in oral and written English; additional language considered a plus.
Previous experience in a pharmaceutical, CRO or medical device company required.
Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155.
Personal Skills
Ability to communicate, problem solve and work effectively in an international team.
Innovative and self‑motivated.
Excellent organization skills and ability to prioritize goals and responsibilities.
Ability to negotiate and communicate with clients professionally.
Proficient computer skills, understanding and assessing technology alternatives and implications for current processes.
Ability to be productive and successful in a dynamic work environment.
#J-18808-Ljbffr
Industry: Lifescience, Pharma, Medtech, Digital Health
Employment Type: Full-time
Job Functions: Clinical Affairs
Location: Meditrial USA, 866 United Nations Plaza, New York, USA
Workplace: Office-based, availability to travel
Responsibilities
Proactively manage project-level operations, including trial timeline, budget, resources with consideration of quality standards and risk mitigation.
Provide efficient and effective updates on trial progress to the Medical Director as requested.
Lead sponsor study start‑up processes, conduct trial kick‑off meetings, set up trial master file (TMF), site selection, and finalize site and vendor Clinical Trial Agreements (CTAs) and budgets.
Ensure effective project plans for each trial, coordinating with the Clinical Trial Team on priorities, SOPs, GCP guidelines, and regulatory requirements.
Attend study update meetings, ensure minutes are completed, distributed, and filed in the TMF timely; review and approve site visit reports, follow‑up on site‑specific issues.
Monitor quality of deliverables, address quality issues with team members, and identify opportunities to improve training, execution, and quality control.
Qualifications
Education: Bachelor’s degree in Life Sciences; Master in health‑related field is a plus.
Languages: Proficiency in oral and written English; additional language considered a plus.
Previous experience in a pharmaceutical, CRO or medical device company required.
Sound knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155.
Personal Skills
Ability to communicate, problem solve and work effectively in an international team.
Innovative and self‑motivated.
Excellent organization skills and ability to prioritize goals and responsibilities.
Ability to negotiate and communicate with clients professionally.
Proficient computer skills, understanding and assessing technology alternatives and implications for current processes.
Ability to be productive and successful in a dynamic work environment.
#J-18808-Ljbffr