Related skills
edc etmf ctms capa ema📋 Description
- Leads clinical studies from planning to execution to meet timelines and quality.
- Develops executable study plans and milestones; maintains timelines.
- Uses data/metrics to drive planning, execution, and risk mgmt.
- Communicates progress, risks, and mitigations to stakeholders.
- Drives site activation, enrollment, and performance actions.
- Oversees study docs (protocols, informed consents, monitoring plans).
🎯 Requirements
- Bachelor’s degree in life sciences or related field.
- 7+ years in clinical ops; 2+ years in study/team leadership.
- Experience with early and late-stage studies; BLA trials preferred.
- Knowledge of CTMS, eTMF, EDC; ICH-GCP, FDA, EMA.
- Strong vendor management and outsourcing experience; budget control.
- Excellent communication and stakeholder management.
🎁 Benefits
- Hybrid work environment.
- Opportunity to impact cell therapy programs.
- Collaborative cross-functional culture.
- Inclusive Equal Opportunity workplace.
- Professional growth and mentorship opportunities.
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