Senior Director, Trial Master File (TMF) Operations
Scorpion Therapeutics, West Conshohocken, Pennsylvania, United States
Role Summary
Senior Director of Trial Master File (TMF) Operations responsible for designing and overseeing Madrigal's in-house TMF document management system to support R&D activities. Leads cross-functional TMF implementation, ensures compliance with ALCOA-CCEA, and develops strategies for efficient collection, archiving, and QA of trial documents from internal and external sources. Builds and mentors the TMF team, develops SOPs, training, and process improvements to maintain inspection readiness across active studies. Responsibilities
Provide leadership and strategic direction across the R&D Department, focusing on the Clinical Management Department, to ensure TMF processes and related documentation are of the highest quality for active in-house and outsourced studies, drawing on quality compliance processes and regulations such as Good Clinical & Documentation Practices Adhere to ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available) Develop standard reporting for ongoing compliance checks by study to be presented at Clinical Study Team meetings and to management Grow and lead a team of direct reports, commensurate with the business requirements, that will support the TMF platforms and each study TMF Develop proactive approaches to process improvements and enhancements of TMF Author and review internal and external TMF-related SOPs, work instructions, and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes) including working with the cross-functional study team to obtain input Ensure inspection-ready TMF and provide expert support for audits and inspections Instill a culture of continuous improvement; act as a change champion and effectively leads change Manage the TMF processes to meet the goals and objectives of the department and maintain inspection readiness for all active studies Create and lead training across all relevant business units/functional areas on Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors Development and oversight of management and maintenance of TMF repositories, including filing, scanning, QC, and inventory of paper documents Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management Support study teams at the end of trial eTMF QC and migration activities, including study documents from all vendors Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance Ad hoc support of activities within the Clinical Management team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed Apply knowledge of ICH-GCP, CFR, and other national and local requirements to develop and improve document management processes Other duties as assigned Qualifications
Required: Bachelor's Degree or higher Required: 15+ years experience leading the TMF activities for a clinical research organization (CRO) and/or in the biotech/pharmaceutical industry; other relevant experience will be considered Required: Leadership skills and experience managing employees and contractors Preferred: Experience with Veeva eTMF platform Preferred: Experience with CDISC Trial Master File Reference model and good understanding of records management best practices Required: Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA Required: Experience with Inspection Readiness Preferred: Hands-on experience in a regulatory body inspection Required: Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process Skills
Excellent attention to accuracy and details Effective written and verbal communication skills Excellent presentation skills, providing information to a large audience Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook) Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment Ability to learn new technologies with ease Solid analytical and proactive problem-solving skills Strong operational skills and demonstrated ability to meet timelines A team player with ability to build relationships at all levels Demonstrated self-starter with a high level of commitment
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Senior Director of Trial Master File (TMF) Operations responsible for designing and overseeing Madrigal's in-house TMF document management system to support R&D activities. Leads cross-functional TMF implementation, ensures compliance with ALCOA-CCEA, and develops strategies for efficient collection, archiving, and QA of trial documents from internal and external sources. Builds and mentors the TMF team, develops SOPs, training, and process improvements to maintain inspection readiness across active studies. Responsibilities
Provide leadership and strategic direction across the R&D Department, focusing on the Clinical Management Department, to ensure TMF processes and related documentation are of the highest quality for active in-house and outsourced studies, drawing on quality compliance processes and regulations such as Good Clinical & Documentation Practices Adhere to ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available) Develop standard reporting for ongoing compliance checks by study to be presented at Clinical Study Team meetings and to management Grow and lead a team of direct reports, commensurate with the business requirements, that will support the TMF platforms and each study TMF Develop proactive approaches to process improvements and enhancements of TMF Author and review internal and external TMF-related SOPs, work instructions, and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes) including working with the cross-functional study team to obtain input Ensure inspection-ready TMF and provide expert support for audits and inspections Instill a culture of continuous improvement; act as a change champion and effectively leads change Manage the TMF processes to meet the goals and objectives of the department and maintain inspection readiness for all active studies Create and lead training across all relevant business units/functional areas on Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors Development and oversight of management and maintenance of TMF repositories, including filing, scanning, QC, and inventory of paper documents Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management Support study teams at the end of trial eTMF QC and migration activities, including study documents from all vendors Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance Ad hoc support of activities within the Clinical Management team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed Apply knowledge of ICH-GCP, CFR, and other national and local requirements to develop and improve document management processes Other duties as assigned Qualifications
Required: Bachelor's Degree or higher Required: 15+ years experience leading the TMF activities for a clinical research organization (CRO) and/or in the biotech/pharmaceutical industry; other relevant experience will be considered Required: Leadership skills and experience managing employees and contractors Preferred: Experience with Veeva eTMF platform Preferred: Experience with CDISC Trial Master File Reference model and good understanding of records management best practices Required: Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA Required: Experience with Inspection Readiness Preferred: Hands-on experience in a regulatory body inspection Required: Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process Skills
Excellent attention to accuracy and details Effective written and verbal communication skills Excellent presentation skills, providing information to a large audience Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook) Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment Ability to learn new technologies with ease Solid analytical and proactive problem-solving skills Strong operational skills and demonstrated ability to meet timelines A team player with ability to build relationships at all levels Demonstrated self-starter with a high level of commitment
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