Title: Senior TMF Lead
Term: Anticipated 1 year, potential to extend
Location: FULLY REMOTE (candidates from NY/NJ/PA/TX only)
- Manage assigned studies; create and maintain the TMF Plan and TMF Index, monitor document submissions and query workflows and delivery monthly Health reports/CRO metrics / Key Performance Indicators, along with strategy / summary of way to improve.
- Manage activities within electronic TMF Management system including: Study set-up, milestones/events, oversee and monitor the completion of study / country / site Completeness reviews, trigger Archival activities at the study close, perform ad hoc system trainings and demos as required for assigned study teams and/or CRO Partners.
- Trigger and manage the activities related to archiving of TMF documents, including obtaining approval from the study team, notifying the Company Archivist, and maintaining electronic logs which contain the location of study documents.
- Oversee the TMF Completeness activities associated with reviews / updates to the EDLs to ensure adherence to SOPS and regulatory requirements. Assist with generating various reports, metrics and analyzing trends across studies, countries and sites.
- Oversee the project teams to ensure the Company study team and outsourced CRO are compliant with eTMF Processes/Procedures and/or management for the correction and resolution of quality issues, TMF completeness and timely submission of documents to the TMF.
- Assist or initiate improvements of departmental SOPs, SWPs, work guidelines or trainings as needed.
- Bachelor’s degree in scientific or technical discipline recommended with minimum of 3-4 years of pharmaceutical industry experience (8+ years of hands on TMF/document management experience will be considered in lieu of a Bachelor’s degree).
- Preferred 3-4 years of experience in TMF/eTMF, clinical document management and/or clinical quality control.
- Good understanding of clinical development, including regulatory documents and regulatory requirements (including ICH and GCP guidelines)
- Experience/ Knowledge/understanding of TMF requirements and technologies (such as PhlexTMF and Veeva Vault) to support document collection and archiving; eTMF experience required
- Strong knowledge of report and Dashboard building in Veeva Vault
- Strong document management skills, including experience with review of Regulatory Documents, be detail oriented, organized, quality driven and able to work in a team environment under tight deadlines
- Good critical reasoning skills, including the identification and resolution of complex problems
- Must be proficient in MS Office
- Strong verbal, written and interpersonal communication skills
- Shows high level of initiative and has ability to work independently
- Very detailed oriented and excellent organizational and time management skills