Study Start-Up Leader
Job ID R0000031382 Category Clinical TrialsAbout this Role
Job Purpose: The Associate Study Start-up Leader/ Study Start-Up Leader is accountable for the execution of the study start-up strategy and planning, including the management and coordination of start-up activities such as alignment to country regulations, Core/Site document collection/ approval, ICF customization/approval, EC and RA/ MoH submissions, SIV scheduling and activation requirements.
The Senior Study Start-Up Leader, is accountable as noted above including:
1. Acting as study-level program lead, such as managing multiple protocol delivery for a Sponsor or asset development.
2. Acting as an Enterprise or Biotech level lead and provide expert level knowledge on agreed partnership process.
3. Additional responsibilities may include:
- Study Start-Up Leader mentorship
- Participation in training and support programs
- Fulfilling subject matter expert or process improvement roles within Clinical Operations
Key Accountabilities:
- Manage the study start up process, through development of a site activation strategy and to oversee start-up delivery and governance.
- Coordinate, develop and articulate the critical path planning, and implement as part of the Site Initiation Scheduling, System Set-up, EDL Management, EC & RA/ MoH Strategy, ICF Customization, Risk Mitigations, Monitoring Plan, Site Activation Requirements & Relevant Tools.
Knowledge and Experience:
- Proven client-facing relevant experience in healthcare, clinical research, project management or contract research organization
- Experience in a multi-national organization
- Prior Project Management experience preferable
- End to End study start-up experience & expertise preferred
- Competent in written and oral English
Education:
- Degree in a life science or relevant clinical trial experience, especially in study start up activities
- Advanced degree preferable
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