Compliance

• Deliver timely and high-quality site activation readiness within assigned country/sites and foresee and mitigate risks
• Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
• Interact with Competent Authorities and Ethics Committees and handle responses
• Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
• Maintain project plans, trackers, and regulatory intelligence tools
• Support development of study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with site CRAs to align communication and secure site collaboration
• Prepare, review, and manage essential documents for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Facilitate document translations and coordinate translations required for submissions
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as subject matter expert for site activation critical-path data, including regulatory timelines, contracts, budgets, and required reviews
• Support study budget negotiations and investigator contract execution when required
• Support feasibility activities and site outreach when needed
• Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine
• Maintain audit/inspection readiness and file documents according to TMF and study-specific plans
• Support Pre-Study Site Visits, process improvement initiatives, training, and mentoring
• Perform other duties assigned by management

Regulatory and Site Start-Up Specialist

• Deliver timely and high-quality site activation readiness within assigned country/sites while identifying and mitigating risks
• Prepare Clinical Trial Application Forms and submission dossiers for Competent Authorities, Ethics Committees, IRBs, and other applicable local bodies
• Interact with Competent Authorities and Ethics Committees and handle responses
• Provide regular submission updates to Start Up/Regulatory Leads and Project Managers/Project Teams
• Maintain project plans, trackers, and regulatory intelligence tools
• Support study-specific start-up plans, IMP release requirements, and essential document review criteria
• Partner with assigned site CRAs to align communication and secure site collaboration
• Prepare, review, and manage essential documents required for site activation and IMP release
• Customize country/site-specific Patient Information Sheets and Informed Consent Forms
• Facilitate document translations and coordinate translation activities
• Coordinate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as subject matter expert for site-level critical path and Site Activation data points
• Support study budget negotiations and investigator contract execution when required
• Support feasibility site outreach when needed
• Maintain knowledge of local clinical trial laws and regulations and distribute knowledge within Precision for Medicine
• Maintain audit/inspection readiness and file documents according to TMF or study-specific plans
• Support Pre-Study Site Visits when needed
• Support process improvement initiatives, training, and mentoring
• Perform other duties assigned by management