This role will work directly within Clinical Operations Group, leading the strategic planning and management of the Corvus Veeva Vault eTMF system. Position will be accountable for overall system management, planning and implementation of clinical studies in the eTMF, as well as developing the global strategy for development and maintenance of electronic tracking and monitoring systems. Also responsible for ensuring overall company compliance with GxP records management requirements, procedures and training programs.
Role and Responsibilities
- Clinical Trial Document Management:
- Lead the Clinical Operations department and other functional groups in the development and maintenance of study specific eTMF management plans
- Ensure required quality and completeness of the expected study documents in all Corvus studies TMFs
- Lead the development and maintenance of SOPs and Work Instructions for the eTMF
- Monitor all eTMF document processing activities to ensure required document quality and adherence to applicable processes and requirements
- Lead study teams to ensure eTMF inspection readiness at all stages of study execution
- Lead the development and oversight of the ongoing eTMF quality and completeness monitoring for all Corvus studies
- Lead the development and maintenance of required eTMF status reports and study metrics
- Lead the development and maintenance of the eTMF archiving processes and associated activities.
- TMF Training:
- Lead the development and coordinate the performance of all required TMF system administration and support personnel training
- Lead the development and coordinate the performance of all required internal Corvus TMF user training
- Lead the development and coordinate the performance of all required external TMF user training
- TMF Vendor Management:
- Lead the development and maintenance of vendor oversight systems and processes
- Collaborate with vendor on the ongoing eTMF system upgrades and system maintenance
- Manage vendor contracts
- Develop trackers for review of the eTMF and provide feedback to the vendor and study team
- TMF System Management:
- Manage release impact assessment for eTMF system upgrades
- Lead the development and maintenance of system and processes for User management and study team assignments for eTMF as per the SOP
- Lead the development and maintenance of system and processes for implementation and maintenance of study-specific system builds
- Collaborate with vendor to assess and implement all features of the eTMF system that are valuable to Corvus
Qualifications and Education Requirements
- 5+ years of clinical trial document management experience and at least 2 years of experience of eTMF system management, preferably Veeva Vault eTMF system
- Experience in direct management of staff, as well as the mentoring and development of junior staff.
- Experience and advanced understanding of Veeva Vault eTMF system
- Veeva Vault System Administrator Certification or ability to complete the certification if hired.
- Advanced working knowledge of DIA Reference Model TMF structure
- Thorough understanding of clinical trial operations activities
- Thorough knowledge and understanding of ICH/GCP guidelines and FDA regulations
- General knowledge of medical terminology
- Computer skills including proficiency in the use of Microsoft Word, Excel, PowerPoint, Outlook, and organization tools
- Experience with filing systems such as SharePoint, Dropbox, and Box are desirable
- Able to build effective working relationships throughout the organization internally and externally to achieve goals.
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Clear and concise verbal and written communication skills and strong organizational skills, with an exceptional attention to detail.
- Work independently in an interdisciplinary, fast-paced, often changing environment.
- Committed to the values of integrity, accountability, transparency, and drive.
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