Related skills
project management ich guidelines regulatory submissions irb good clinical practice📋 Description
- Manage the site start-up process and activation readiness strategy.
- Coordinate critical path: IRB/EC, MoH strategy, ICF customization, risk mitigations.
- Collaborate with stakeholders to secure milestone input and align goals for activation.
- Lead client meetings to set expectations, risks, and status reporting.
- Partner with Leaders and Site Start-Up Specialists to identify risks and mitigations.
- Oversee real-time progress tracking and translations for submissions.
🎯 Requirements
- Bachelor's degree in life sciences or RN or equivalent.
- 5+ years in start-up, ideally SU Lead or PM in CRO/pharma/biotech.
- 2+ years in project milestone management, coordinating resources and budgets.
- Demonstrated leadership in cross-functional activities.
- Excellent communication and organizational skills; fluent in English; local language for non-English locations.
- Experience with information systems, spreadsheets, MS Office, and milestone tracking tools.
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