4 дня назад
Project Manager, Feasibility Site Activation (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Project Manager, Feasibility Site Activation (Clinical Research): Leading study start-up strategies and site activation for global, multi-country clinical studies with an accent on regulatory submissions, ethics approvals, contracts, budgets, and milestone delivery. Focus on coordinating cross-functional teams, mitigating start-up risks, maintaining inspection-ready documentation, and ensuring efficient activation across participating countries.
Location: Home-based in Poland, Bulgaria, Czechia, Georgia, Hungary, Ireland, Latvia, Portugal, Romania, Serbia, Slovakia, Spain, or the UK. Remote or office working is available.
Company
is a healthcare intelligence and clinical research organization focused on supporting clinical development and improving patient outcomes.
What you will do
- Shape and execute Study Start-Up strategies for global, multi-country clinical studies.
- Develop and deliver plans covering regulatory, ethics, contract, and budget activities.
- Lead end-to-end start-up from site identification through IP release and site activation.
- Oversee regulatory and ethics submissions, site contract negotiations, budgets, risks, dependencies, and milestones.
- Coordinate start-up teams and cross-functional stakeholders while providing structured reporting to sponsors and leadership.
- Maintain study documentation, CTMS and eTMF oversight, metrics, scope, and inspection readiness.
Requirements
- Recent primary responsibility for Study Start-Up and end-to-end site activation activities.
- Experience delivering start-up activities across global or multi-country clinical studies.
- Strong knowledge of regulatory and ethics submissions, including CA/EC and CTA strategy.
- Experience coordinating site contracts and budgets within start-up timelines.
- Familiarity with CTMS, eTMF, clinical trial systems, ICH-GCP, and applicable regulatory frameworks.
- Strong stakeholder management, communication, risk management, and cross-functional collaboration skills.
Culture & Benefits
- Home-based working with flexible country-specific benefits.
- Annual leave and health insurance options for employees and families.
- Retirement planning offerings and life assurance.
- Global Employee Assistance Programme with 24-hour access to wellbeing support.
- Optional benefits may include childcare vouchers, bike purchase schemes, gym memberships, travel passes, and health assessments.
- Inclusive workplace committed to equal opportunity, accessibility, and belonging.
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