Interaction with competent authorities/ethics committees
Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to support site activation processes in clinical trials. The ideal candidate should have a background in life sciences and at least one year of relevant experience in regulatory affairs or site start-up within the CRO or pharmaceutical industry
Job Summary
Responsible for the timely and quality delivery of site activation readiness within assigned countries/sites, foreseeing and mitigating risks.
Prepares Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies according to regulations and ICH-GCP.
Maintains updated knowledge of local clinical trial laws and regulations, ensuring compliance and audit/inspection readiness.
Matching Summary
Match Score: 85
Precision for Medicine is seeking a Regulatory and Site Start Up Specialist to support site activation processes in clinical trials. The ideal candidate should have a background in life sciences and at least one year of relevant experience in regulatory affairs or site start-up within the CRO or pharmaceutical industry.
Skills & Requirements
Must-have
site activation readiness
submission dossier preparation
interaction with Competent Authorities/Ethics Committees
maintenance of project plans and trackers
essential document collection
translation coordination
audit and inspection readiness
Nice-to-have
passion for rare diseases and oncology
strong communication skills
organizational skills
Key Requirements
Bachelor's degree in life sciences or related field, RN, or equivalent experience