Regulatory and Site Start-Up Specialist

📋 Description

• Accountable for ensuring timely and high-quality site activation readiness within the designated country/sites while identifying and mitigating potential risks.

• Preparation of Clinical Trial Application Forms and submission dossiers (initial and amendments/notifications) for regulatory authorities, Ethics Committees, and other relevant local entities in accordance with local requirements and timelines to secure necessary authorizations/approvals for conducting Clinical Trials as per international and local/national regulations, company SOPs, and ICH-GCP principles.

• Engage with Competent Authorities/Ethics Committees for study-related purposes and manage responses to these entities.

• Provide consistent updates regarding CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study, as well as to the Project Manager/Project Team.

• Maintain project plans, trackers, and regulatory intelligence tools related to assigned responsibilities, ensuring that Regulatory Leadership is kept informed.

• Assist in the development of study-specific start-up plans, IMP release requirements, and criteria for essential document review.

• Collaborate with the assigned site CRA to ensure effective communication, secure site reviews, and manage the collection of essential documents needed for site activation/IMP release.

• Tailor the Patient Information Sheet and Informed Consent Form to meet country/site specific requirements.

• Oversee or facilitate the translation and coordination of document translations.

• Maintain communication with other key functions involved in country start-up, such as Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group regarding project-specific status and deliverables.

• Act as a subject matter expert for collecting and maintaining site-level critical path data points for Site Activation, including Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts, and budget negotiation requirements to ensure timely site activation for assigned sites in the country.

• When necessary, participate in or support the negotiation of study budgets and the execution of investigator contracts under the guidance of the Site Contract Management department or designated department.

• May assist the feasibility group in site outreach to gauge potential investigator interest in a forthcoming study.

• Stay updated on local clinical trial laws and regulations, and help disseminate this knowledge within PFM to ensure compliance with international and local/national regulations in conducting Clinical Trials.

• Maintain audit/inspection readiness at all times and file documents according to the TMF plan and/or study-specific plans in the appropriate TMF.

• May support the clinical team in conducting Pre-Study Site Visits.

⛳️ Requirements

• Bachelor’s degree in life sciences or a related field (preferably in a scientific or healthcare discipline), or Registered Nurse (RN) or an equivalent combination of education, training, and experience.

• A qualification in Pharmacy or experience as a Pharmacist would be highly advantageous.

• At least 1 year of experience as a Regulatory or Start-Up specialist (or in a comparable role) within a CRO or pharmaceutical/biotech industry, or relevant equivalent experience and/or demonstrated competencies.

• Excellent communication and organizational skills.

• Proficiency in using computerized information systems, electronic spreadsheets, word processing, and email is required.

• Fluency in English.

🏝️ Benefits

• Health insurance

• Flexible working hours