Clinical Operations Lead
On-siteLeiden, South Holland, The Netherlands
Job Summary
Manage end-to-end operations for outsourced clinical trials as the primary liaison between the organization and external service providers. Ensure assigned studies meet timelines, budgets, and quality standards while proactively mitigating risks throughout the clinical trial lifecycle. Provide hands-on oversight for data integrity and patient safety, including the setup and maintenance of the Trial Master File. This role requires a hands-on mentality and strong project planning skills to drive operational excellence in a fast-paced environment. You will work cross-functionally to support the Development Department's mission of editing RNA to treat disease.
Required Qualifications
- Minimum Bachelor's degree in a life science-related field
- Minimum 5 years of experience as Clinical Operations Lead in management of global clinical trials
- Proven track record of managing outsourced clinical trials
- Proven track record of CRO oversight
- Excellent knowledge of the ICH-GCP guidelines
- Knowledge of relevant EMA/FDA regulations
- Knowledge of the clinical development process
- Experience in Phase 1-2 clinical trial management
- Experience in selecting and managing External Service Providers (ESP)
- Experience in qualification of ESP
- Experience in set-up of ESP
- Experience in project management oversight of ESP
- Experience in performance assessments of ESP
- Experience in finance management of ESP
- Hands-on mentality
- Team player
- Ability to work in a fast-paced environment
- Strong project planning and management skills
- Ability to prioritize multiple tasks
- Critical thinking, decision-making, and problem-solving skills
- Excellent communication skills
- Proactive and pragmatic self-starter
- Result-oriented mindset
Desired Qualifications
- Advanced degree in a health-related field
- Previous experience working with EDC systems
- Previous experience working with eTMF systems
- Previous experience working with CTMS systems
- Knowledge of some widely used eTMF/CTMS systems in multi-center, multi-national trial settings (e.g. Veeva Vault, Medrio, Medidata Rave, ClinSpark, etc.)
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