Start Up Lead APAC
P
Precision for MedicineClinical Research
Location : Based in Australia/Singapore/South Korea/Taiwan/China.Full-TimeLead
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, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent; 2 years or more experience in project milestone management.
- Required Skills
- Project ManagementMicrosoft OfficeStakeholder management
Requirements
- Bachelor's degree in life sciences or related field, or Registered Nurse (RN) qualification.
- 5+ years of experience in site start-up, with preference for SU Lead or Project Management experience in a CRO or pharmaceutical/biotech setting.
- 2+ years of experience in project milestone management, resource management, and budget coordination.
- Demonstrated leadership experience in driving cross-functional activities.
- Fluency in English is required; fluency in the local language of the country of employment is required for non-English speaking locations.
- Proficiency in computerized information systems, electronic spreadsheets, word processing, and electronic mail.
- Experience using milestone tracking tools and systems.
- Excellent communication and organizational skills.
Responsibilities
- Manage the site start-up process through the development of an activation readiness strategy.
- Coordinate and present critical path planning, including IRB/EC and CA/MoH strategy, ICF customization, and IMP release requirements.
- Collaborate with stakeholders to align operational goals and ensure timely delivery of site start-up activities.
- Participate in client meetings to establish expectations, communication plans, and risk mitigation strategies.
- Provide oversight to ensure tracking systems are maintained for analysis of progress metrics against study targets.
- Act as a Subject Matter Expert (SME) to mentor staff on local regulations, submissions, and internal procedures.
- Support the development of country-specific process flows, identifying timelines, risks, and success factors.
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