Precision for Medicine (PFM) is seeking a Regulatory and Start Up Specialist to join their remote team. The role involves overseeing the site activation process for clinical trials, ensuring compliance with regulatory requirements and maintaining communication with various stakeholders
Job Summary
Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.
Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies.
Maintain an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
Matching Summary
Match Score: 85
Precision for Medicine (PFM) is seeking a Regulatory and Start Up Specialist to join their remote team. The role involves overseeing the site activation process for clinical trials, ensuring compliance with regulatory requirements and maintaining communication with various stakeholders.
Skills & Requirements
Must-have
site activation readiness
clinical trial application forms
submission dossier preparation
interaction with competent authorities
maintenance of project plans
essential document collection
patient information sheet customization
informed consent form customization
translation coordination
communication with key functions
collection of site level data
audit/inspection readiness
Nice-to-have
passion for rare diseases and oncology
advanced biomarker and data analytics solutions
novel clinical trial designs
Key Requirements
Bachelor’s degree in life sciences or related field
Registered Nurse (RN)
Demonstrated experience as a Regulatory or Start Up specialist