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Precision for Medicine is a Clinical Research Organization specializing in precision medicine, rare diseases, and oncology. We are seeking a Regulatory and Start-up Specialist to join our growing team and support clinical trial operations across multiple countries.
You will be responsible for ensuring timely and high-quality site activation readiness within assigned countries and sites, while identifying and mitigating regulatory risks. Key responsibilities include:
• Prepare Clinical Trial Application Forms and submission dossiers (initial and amendments) for submission to Competent Authorities, Ethics Committees, and other local regulatory bodies according to local requirements and international standards (ICH-GCP).
• Manage interactions with Competent Authorities and Ethics Committees, handling submissions and responses to secure necessary approvals for clinical trial conduct.
• Provide regular updates on regulatory submissions to Start-up Leads, Regulatory Leads, and Project Managers.
• Maintain project plans, trackers, and regulatory intelligence tools; keep Regulatory Leadership informed of progress and status.
• Develop and support study-specific start-up plans, IMP release requirements, and essential document review criteria.
• Partner with assigned Clinical Research Associates (CRAs) to ensure alignment and secure site review and collection of essential documents for site activation and IMP release.
• Customize country and site-specific Patient Information Sheets and Informed Consent Forms.
• Coordinate document translations and manage translation workflows.
• Maintain communication with key functions (Feasibility, Clinical Operations, Project Management, Regulatory, Site Contracts) on project status and deliverables.
• Act as subject matter expert for site-level critical path data, including Competent Authority and Ethics Committee timelines, site contracts, and budget requirements.
• Support negotiation of study budgets and execution of investigator contracts under direction of Site Contract Management.
This role requires strong regulatory knowledge, attention to detail, and ability to manage multiple concurrent clinical trial activations across different regulatory environments.
