Start Up Lead
P
Precision for MedicineClinical Trial Services
The position could be covered fully remotely from Serbia, Romania, Hungary, Slovakia or Poland.Full-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Fluency in English and for non-English speaking countries the local language of country where position based.
- Experience
- 5 years or more in start up
- Required Skills
- Project ManagementMS OfficeBudget management
Requirements
- Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent.
- 5 years or more in start up, ideally with Start Up Lead or PM experience in a CRO or pharmaceutical/biotech industry.
- 2 years or more experience in project milestone management, managing resources, budgets, and coordinating team activities.
- Demonstrated leadership experience in driving cross-functional activities.
- Fluency in English and the local language of the country where the position is based.
- Proficiency in computerized information systems, electronic spreadsheets, word processing, and electronic mail.
- Experience using milestone tracking tools/systems.
- Solid knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements.
- Excellent communication, organizational, and time management skills.
- Ability to work independently in a fast-paced environment.
Responsibilities
- Manage the site start-up process through development of an activation readiness strategy.
- Coordinate, develop and present 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 delivery of site start-up activities.
- Participate in client meetings to establish expectations, communication, and risk mitigation strategies.
- Provide oversight to ensure tracking systems are maintained for analysis of progress metrics at study, country, and site levels.
- Mentor and train staff on local study start-up regulations, submissions, and internal procedures.
- Support the development of country-specific summary and process flows for site start-up.
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