Start Up Lead
New
P
Precision for MedicineClinical Trial Services
Remote, TurkeyFull-TimeLead
Salary not disclosed
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Job Details
- Languages
- English and Turkish
- Experience
- 2 years or more experience
- Required Skills
- Project ManagementGCPMicrosoft Office
Requirements
- Bachelor's degree in life sciences, or Registered Nurse (RN), or equivalent combination of education and experience.
- Minimum 2 years of experience in project milestone management, managing resources, and coordinating team activities.
- Proven experience in site start-up processes from a CRO or pharmaceutical/biotech industry.
- Demonstrated leadership experience in driving cross-functional activities.
- Fluency in English and Turkish.
- Proficiency in computerized information systems, electronic spreadsheets, word processing, and electronic mail.
- Experience using milestone tracking tools and systems.
- Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements.
- Strong communication, organizational, and time management skills.
Responsibilities
- Manage the site start up process through development of an activation readiness strategy.
- Coordinate critical path planning including IRB/EC & CA/MoH Strategy, ICF Customization, and IMP Release Requirements.
- Collaborate with stakeholders to ensure alignment of operational goals and timely activation.
- Participate in client meetings to establish expectations, communication plans, and risk mitigation strategies.
- Provide oversight to ensure accuracy of tracking systems for study, country, and site-level metrics.
- Act as a Subject Matter Expert and mentor staff on local study start-up regulations and internal procedures.
- Support the development of country-specific start-up summaries and process flows.
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