Regulatory and Site Start Up Specialist

Job Description

We are seeking a Regulatory and Site Start Up Specialist to ensure the efficient and compliant activation of clinical trial sites. The specialist will be responsible for: - Delivering timely and high-quality site activation readiness within assigned countries/sites, proactively identifying and mitigating potential risks. - Preparing Clinical Trial Application Forms and submission dossiers (initial, amendments, notifications) for Competent Authorities, Ethics Committees, and other local bodies, adhering to local requirements and timelines. - Interacting with CA/EC for study purposes and managing responses. - Providing regular updates on CA and EC submissions to the Start Up Lead, Regulatory Lead, Project Manager, and Project Team. - Maintaining project plans, trackers, and regulatory intelligence tools related to assigned responsibilities. - Preparing and supporting the development of study-specific start-up plans, IMP release requirements, and essential document review criteria. - Collaborating with site CRAs to ensure aligned communication and secure site review, managing the collection of essential documents for site activation/IMP release. - Customizing country/site-specific Patient Information Sheets and Informed Consent Forms. - Coordinating and facilitating document translations. - Maintaining communication with key functions (Feasibility, Clinical Operations, Project Management, Regulatory, Site Contracts) on project status and deliverables. - Acting as an SME for collecting and maintaining site-level critical path data points for Site Activation, including Competent Authority, local IRB/Ethics Committee timelines, site contracts, and budget negotiation requirements. - Participating in budget negotiations and investigator contract execution under Site Contract Management department direction. - Supporting feasibility group in site outreach to assess investigator interest in potential studies. - Maintaining up-to-date knowledge of local clinical trial laws and regulations, disseminating this knowledge within PFM. - Maintaining audit/inspection readiness and filing documents per TMF plan and study-specific plans. - Supporting the clinical team in performing Pre-Study Site Visits.

Qualifications

1. Bachelor’s degree in life sciences or a related field (scientific or healthcare discipline), or Registered Nurse (RN) or equivalent. 2. Qualification in Pharmacy/work experience as a Pharmacist is highly beneficial. 3. Minimum of 1 year of experience as a Regulatory or SU specialist (or comparable role) in a CRO or pharmaceutical/biotech industry. 4. Strong communication and organizational skills. 5. Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail. 6. Fluency in English.

Benefits

- Health insurance - Professional development opportunities