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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. This is a fully remote position.
The Start Up Lead is an expert in global site start-up activities and owns the execution of site start-up strategy and planning. Key responsibilities include managing and coordinating Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/MoH submissions, and delivery of quality IMP release packages. You will serve as a Subject Matter Expert for in-country teams (SUSs, CRAs, CSSs) and provide training on site start-up activities.
Core responsibilities:
• 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 IMP release requirements
• Collaborate with stakeholders to align operational goals and ensure timely delivery of start-up activities
• Participate in client meetings to establish expectations for delivery, communication, risk mitigation, and reporting
• Partner with Functional Leaders and Site Start-up Specialists to identify and mitigate delivery risks
• Maintain real-time tracking systems and analyze progress metrics against targets at study, country, and site levels
• Coordinate translations for submission documents
• 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-specific start-up summary development and process flow documentation
• Develop and facilitate training sessions to expand start-up knowledge
• Mentor staff on local study start-up regulations, submissions, and procedures
• Support proposal activities including slide development and client presentations
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 PM 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 assigned country
• 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 commitment to accuracy
• Ability to work independently in fast-paced environments with urgency
• Excellent computer skills
• Strong time management and prioritization abilities
• Excellent written and spoken communication, presentation, and interpersonal skills
• Occasional travel may be required
