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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 package delivery. You will serve as a Subject Matter Expert for in-country teams (Site Start-up Specialists, CRAs, Clinical Site Specialists), provide training on start-up activities, and own country-specific tools and guidance documents.
Essential functions include:
- Develop and execute activation readiness strategies and critical path planning for IRB/EC, regulatory authority, ICF customization, risk mitigation, and contract execution
- Coordinate with stakeholders to establish milestone planning and align operational goals for timely site activation
- Participate in client meetings to set expectations for delivery, communication, risk mitigation, and metrics
- Partner with functional leaders and Site Start-up Specialists to identify and mitigate delivery risks
- Oversee tracking systems and maintain real-time progress analysis against targets 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, local reviews, site contracts, budget requirements)
- Support development of country-specific start-up summaries and process flows
- Develop and facilitate training sessions; mentor staff on local regulations, submissions, and procedures
- 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 Site Start-up 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/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 with ability to inform, influence, and persuade
