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Precision for Medicine is seeking a Start Up Lead to join its European team, supporting clinical trial site activation across Serbia, Romania, Hungary, Slovakia, and Poland.
You will be an expert in global site start-up activities, accountable for executing site start-up strategy and planning. Key responsibilities include managing and coordinating core/site document collection and approval, ICF customization, IRB/EC and regulatory submissions, and IMP release packages. You will serve as a Subject Matter Expert for in-country teams (Site Start-up Specialists, CRAs, Clinical Site Specialists), mentor less-experienced staff, and own country-specific tools and guidance documents.
Essential functions include:
• Develop and execute activation readiness strategies to oversee site start-up delivery
• Coordinate critical path planning including IRB/EC, CA/MoH strategy, ICF customization, risk mitigation, and contract execution
• Collaborate with stakeholders to align operational goals and ensure timely site activation
• Participate in client meetings to establish expectations for delivery, communication, and risk mitigation
• Partner with Functional Leaders and Site Start-up Specialists to identify and mitigate delivery risks
• Oversee tracking systems and maintain real-time progress metrics at study, country, and site levels
• Coordinate document translations for regulatory submissions
• Maintain communication with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams
• Act as SME for site-level critical path data (IRB/EC timelines, site contracts, budget requirements)
• Support country-level start-up activities as needed
• Develop country-specific start-up summaries and process flows
• Develop and facilitate training sessions; mentor staff on local regulations and procedures
• Support proposal activities and client presentations
• Occasional travel may be required
REQUIREMENTS:
Minimum Required:
• Bachelor's degree in life sciences or related field, OR Registered Nurse (RN), or equivalent combination of education, training, and experience
• 5+ years in start-up activities, ideally with Site Start-up Lead or Project Manager experience in a CRO or pharmaceutical/biotech industry
• 2+ years experience in project milestone management, managing resources, budgets, and coordinating team activities
Other Required:
• Demonstrated leadership experience driving cross-functional activities
• Excellent communication and organizational skills
• Experience with computerized information systems, electronic spreadsheets, word processing, and email
• Fluency in English and the local language of the country where positioned
• Experience with milestone tracking tools/systems
Preferred:
• Advanced degree in life sciences or related field
Competencies:
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
• Attention to detail and accuracy
• Ability to work independently in fast-paced environments with urgency
• Excellent computer skills
• Strong time management and prioritization
• Excellent written and spoken communication, presentation, and interpersonal skills
