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Precision for Medicine seeks a Start Up Lead to join its European team, managing clinical trial site activation across Eastern Europe. This is a senior individual contributor role focused on executing site start-up strategy and coordinating complex regulatory and operational activities.
Key Responsibilities:
• Develop and execute site activation readiness strategies, overseeing the full start-up delivery process.
• Coordinate critical path planning including IRB/EC submissions, CA/MoH approvals, ICF customization, IMP release requirements, and contract execution.
• Collaborate with stakeholders (clients, functional leaders, site start-up specialists) to establish expectations, align operational goals, and ensure timely activation.
• Participate in client meetings to present delivery timelines, communication plans, risk mitigation strategies, and metrics.
• Proactively identify risks to delivery timelines and develop mitigation strategies in partnership with functional leaders.
• Maintain real-time tracking systems and provide oversight of progress metrics against targets at study, country, and site levels.
• Coordinate document translations for regulatory submissions.
• Maintain communication with feasibility, clinical operations, project management, regulatory, and contracts teams.
• Serve as subject matter expert (SME) for country-specific critical path data, including local IRB/EC timelines, site contracts, budget requirements, and activation prerequisites.
• Support country-level start-up activities directly when needed.
• Develop country-specific start-up summaries and process flows identifying timelines, risks, and success factors.
• Develop and facilitate training sessions on country start-up procedures and act as SME for staff queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures, and SSDL.
• Support proposal activities including slide development 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 SU Lead or Project Manager experience in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and demonstrated competencies.
• 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 (GCP), ICH Guidelines, and applicable regulatory requirements.
• Attention to detail and commitment to accuracy.
• Ability to work independently in fast-paced environments with urgency.
• Strong computer skills.
• Excellent time management and prioritization.
• Strong presentation, interpersonal, and persuasion skills (written and spoken).
