Were expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and were looking for an experienced Trial Master File TMF Lead II to help build the foundation of this new regional function in LATAM!
Our TMF Lead II is responsible for supporting project teams in maintaining a high quality Trial Master Files in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision Standard Operating Procedures (SOPs). The TMF Lead II supports a range of studies across the Precision Medicine Group portfolio.
Responsibilities:
- Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high level of quality
- Create and execute the study TMF Plan and project TMF Document Index. Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team
- Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF
- Attend and contribute to project kick-off meetings, project internal or external meetings, and ad hoc meetings as needed to ensure the project team is aware of the status of the TMF, potential gaps and escalations
- Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state
- Ensure that TMF Risks are identified and appropriately documented and mitigated
- Monitor and report on TMF Health and Metrics and escalate non-compliances and potential issues to internal team and Senior Leadership as required
- Identify trends, risks, and overall status of the TMF and suggest mitigation strategies
- Support Audits and Inspections and finding resolutions and participate in Audit/Inspection interviews with support and oversight from Line Management
- Ensure that Periodic Quality Review for assigned projects is initiated and performed by the Quality Review Specialists and ensure proper documentation
- Ensure that document review and processing for assigned projects is performed by the Document Specialists on a timely and consistent basis
- Identify project team TMF training needs and provide or support team re-education
- Manage the close-out activities of assigned studies, including defining the timeline for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfer to the sponsor and collect the Acknowledgement of Receipt
- Where needed, manage projects within the Sponsor eTMF System
- Monitor and report potential out of scope activities related to Records Management and communicate this to TMF manager for support
Minimum Education & Experience:
- Bachelors degree (or its international equivalent)
- A minimum of 3 years of related experience Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job.
- Professional working proficiency in English
Knowledge, Skills, and Competencies:
- Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint)
- Experience with eTMF systems and vendors
- Working knowledge of FDA & ICH/GCP regulations and guidelines
- Demonstrates solid interpersonal skills
- Ability to identify issues and escalate appropriately and effectively
- Good organizational skills, time management, and ability to coordinate workload and meet established deadlines
- Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
- Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders
- Communicates both verbally and in written form in an efficient and professional manner
- Demonstrates values and a work ethic consistent with Precision Values and Company Principles
#LI-AG2 #LI-REMOTE
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