Project management of and accountable for timely preparedness of eTMFs by maintaining oversight of schedules to ensure accessibility and archival of essential regulatory documents
Oversight of eTMF team(s) responsible for ensuring accurate coding and filing of all essential study documents according to SOPs and ICH GCP
Ensure establishment of SOP compliant study-specific Trial Master File Plans
Ensure Clinical Trial Master Files are maintained with an inspection-ready strategy
Oversee implementation and management of eTMF applications
Oversee training of eTMF team along with training for internal or external eTMF users
Development and revisions of eTMF SOPs, work instructions and processes and forms, as needed, for continuous process improvement and to ensure compliance with ICH GCP
Ensure quality checks are performed as per SOPs and monitor staff progress in resolution of identified eTMF discrepancies
Serve as subject matter expert on domestic/international documentation requirements
Establish and oversee eTMF Key Performance Indicator metrics and corrective actions when needed
Ensure routine distribution of eTMF status reports and updates to Clinical Operations and/or Project Team(s)
Represent the clinical document management function both internally and externally, when applicable
Oversight of eTMF migrations, transfers and file-location mapping documentation to/from CROs and partners, as applicable
Work in collaboration with all applicable functional areas and external resources to resolve gaps in the eTMF
Ensure document quality and compliance through active engagement with clinical/project study teams and management
Participate as an SME during audits / inspections of Clinical Operations and the eTMF and interact with auditor/inspector to address queries
Perform other tasks and assignments as needed and specified by management
Job Requirements Requirements:
Bachelor's degree in a relevant discipline
Minimum of 10 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment in roles focused on clinical trial documentation, inclusive of both project and line management skills is preferred.
Inclusive of 4-5 year experience managing eTMFs for pharmaceutical/biotechnology or clinical research organization.
Experience providing guidance to team members, with demonstrated experience in motivating teams, setting up goals, and providing leadership.
Proficiency with eTMF technology and applications including prior, demonstrated experience managing eTMF systems and/or service providers is required.
Thorough knowledge eTMF filing requirements and a demonstrated understanding of records management best practices.
Experience with Veeva Vault eTMF software is highly desirable
Demonstrated understanding of the clinical drug development process and clinical trial methodology.
Demonstrated current knowledge of ICH, GCP and other regulatory guidance as applicable to management of clinical documentation.
Demonstrated ability to assess current and future business needs to ensure the clinical documentation function is strategically and operationally positioned to properly support the Clinical Operations, Regulatory Affairs and Clinical QA
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Able to attend off-site meetings/training/conferences as needed
Experience leading and/or contributing to the selection and/or implementation of an electronic eTMF
Experience supporting regulatory submissions and inspections preferred
Knowledge and experience with CTMS a plus Ability to build strong relationships with co-workers of various backgrounds and expertise
Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
Ability to multitask across projects
Values-based leadership consistent with GBT's Core Values
According to the US Bureau of Labor Statistics (BLS), employment in life, physical, and social science occupations is projected to grow 5 percent from 2019 to 2029, faster than the average for all occupations, and will result in about 68,200 new jobs. Increasing demand for expertise in the sciences, particularly in occupations involved in biomedical research, psychology, energy management, and environmental protection, is projected to result in employment growth.
According to BLS, the median annual wage for life, physical, and social science occupations was $69,760 in May 2020, which was higher than the median wage for all occupations of $41,950.
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