Start Up Lead (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Start Up Lead (Clinical Research): Managing global site start-up activities and execution of start-up strategies for clinical trials with an accent on document collection, IRB/EC submissions, and milestone planning. Focus on coordinating critical path planning, mitigating delivery risks, and mentoring staff on local regulations.
Location: Remote (Must be based in Turkey)
Company
is a global clinical research organization (CRO) providing specialized services for the pharmaceutical and biotech industries.
What you will do
- Manage the site start-up process by developing activation readiness strategies and overseeing delivery.
- Coordinate critical path planning, including IRB/EC & CA/MoH strategies, ICF customization, and IMP release requirements.
- Collaborate with stakeholders to align operational goals and ensure timely site activation.
- Identify risks to delivery and execute mitigation plans to maintain project timelines.
- Act as a Subject Matter Expert (SME) for country-specific start-up requirements and maintain tracking systems in real-time.
- Mentor and train staff on local study start-up regulations, submissions, and internal procedures.
Requirements
- Must be based in Turkey.
- Bachelor's degree in life sciences, related field, or Registered Nurse (RN) qualification.
- Experience in site start-up within a CRO or pharmaceutical/biotech industry.
- 2+ years of experience in project milestone management, resource allocation, and budget coordination.
- Fluency in English and the local language (Turkish) is required.
- Strong knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
Nice to have
- Advanced degree in life sciences or a related field.
Culture & Benefits
- Remote work arrangement.
- Opportunity to act as a Subject Matter Expert and mentor within a global team.
- Equal Opportunity Employer environment.
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