Associate Director Clinical Systems
1 month ago
Position Title: Associate Director, Clinical Systems
Location: Corporate Headquarters, San Diego, CA
Position Type: Full-Time
Job Summary:
The Key Contributor will be responsible for the operational leadership and oversight of the Clinical Systems function within Clinical Operations. This includes overseeing the electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS). The successful candidate will ensure the consistent use and application of technology and standards, ensuring complete and accurate documentation and management of study data across all programs.
Responsibilities:
- Lead the Clinical Systems function, acting as a subject matter expert (SME) and system administrator for Clinical Operations systems.
- Partner internally and externally to implement and maintain high-quality, efficiently designed clinical systems including eTMF and CTMS.
- Manage all aspects of Veeva eTMF/CTMS and applicable analytics tools including system administration, training, and SOPs.
- Ensure eTMF/CTMS are always inspection-ready and compliant with relevant regulations; act as the SME for inspections and audits.
- Serve as a technical liaison to internal and external stakeholders for escalated system issues; ensure systems are fully utilized and current.
- Lead systems vendor selection and perform ongoing service provider management and oversight.
- Monitor key performance indicators (KPIs) and conduct analysis to identify root causes for issues and recommend process improvements.
- Partner cross-functionally to develop and implement relevant Clinical Systems trainings, processes, and procedures.
- Evaluate emerging trends, technologies, and best practices; provide recommendations and direction on strategic roadmaps.
Qualifications:
- BS/BA degree in a related discipline with 7+ years of clinical operations and clinical systems experience in biotech/pharma.
- Extensive experience working with Veeva Vault eTMF and CTMS.
- Ability to understand system interdependencies and drive strategic changes.
- Experience in clinical trial planning and execution preferred.
- Knowledge of computer validation and global regulatory requirements for eTMF management.
- Expertise in managing third-party vendors and applied GxP experience in pharmaceutical or biotech industries.
- Strong stakeholder management, problem-solving, and analytical skills.
Skills and Knowledge:
- Up-to-date knowledge of Clinical Operations processes and Information Systems.
- Proficiency in managing third-party vendors and delivering expected services.
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