Senior TMF Specialist

Overview

Senior TMF Specialist

LATAM Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

This position will support VaxTRIALS, an Emmes Company. VaxTRIALS, as the Latin American expert CRO, provides our customers with a diverse and broad portfolio of Clinical Study Services, either in a full or hybrid fashion for interventional or non-interventional trials, be it pre- or post-authorization, sponsored by manufacturers or investigators. The Senior TMF Specialist, under the guidance of Associate Manager - TMF Operations, is a functional lead for study TMF and is responsible for driving the TMF to be inspection ready by means of identifying completeness gaps in the TMF, generating and creating visibility of meaningful TMF metrics to get the project teams to complete their TMF related tasks, functionally supporting the TMF Specialist activities, and implementing the Quality framework of TMF activities on assigned studies. They are also responsible for the overall management and maintenance of essential clinical trial documents with high quality from set up through maintenance and close out of the TMF, with a strong focus on ensuring that routine TMF tasks are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines. This position plays a key role in managing internal and external

stakeholders’ expectations.

Responsibilities

• Acts as an SME on eTMF applications, TMF processes, document identification/filing and project team processes that result in TMF document generation/collection.
• Owns the TMF Plan/Index and leads the identification of expected documents by finding ways and means to stay abreast of the study events.
• Review the SoW to understand the scope of work and align TMF requirement to it. Delineate between in scope vs out of scope TMF activities. Build relationships with sponsor counterpart keeping Project Manager/Leader in loop to partner with them and provide inputs on best industry practices, especially if sponsor eTMF is used for assigned studies.
• Ensures the TMF file structure follows applicable company approved TMF configuration, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model, as required.
• Contribute to mentoring and grooming TMF Specialists’ TMF related competencies.
• Represents TMF Operations during internal/external/sponsor audits and manage findings through effective resolution both operationally and within the Veeva Vault.
• Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.) to ensure that TMF Operations tasks are performed in adherence with ICH/GCP/regulatory guidelines and best practices.
• Support implementation of features and contribute to change management related to usage of Veeva Vault eTMF system in conjunction with the Clinical Systems Manager.
• Acquires expertise in eTMF applications used for studies where sponsor eTMF is chosen as TMF repository.
• Contributes to streamlining the processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI)/Machine Learning (ML).
• Perform tasks within eTMF application to maintain the lifecycle of the TMF (e.g., TMF set-up, EDL maintenance, reports and metrics, initiate/follow up/close out/perform periodic review, TMF close out/archival, etc.)
  
  

Qualifications

• Bachelor's degree requited, preferably in scientific discipline.
• Incumbent typically will possess 3+ years of Clinical Operations/managing expected documents experience in TMF Operations.
• Knowledge of filing procedures and eTMF application is mandatory.
• knowledge of GCP and TMF governing regulations, such as the TMF Reference Model required.
• Prior experience in maintaining the TMF inspection ready and/or identifying TMF completeness gap is mandatory.
• Experience in Veeva is highly desirable.
• Project management experience is desirable.
• Excellent verbal and written presentation, and communication skills along with fluency in English are necessary.
  
  

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