Lead TMF Specialist

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

The Lead TMF Specialist 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 overseeing 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.

• 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.)

• Bachelor's degree requited, preferably in scientific discipline.
• Incumbent typically will possess 7+ years of Clinical Operations/managing expected documents experience in TMF Operations.
• Knowledge of filing procedures and eTMF application is mandatory.
• 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.
• Competent computer skills including ability to take on board new systems.
• Capability of managing competing priorities in a changeable environment and ability to handle stressful situations/deadlines.
• Thorough knowledge of GCP and TMF governing regulations, such as the TMF Reference Model required. 
• Experience in NIH-sponsored clinical programs is a plus. Assertiveness, strong technical background, integrity, negotiation skills.
• Excellent organizational, planning, analytical, and problem-solving skills. Attention to
  detail required.
• Ability to build and maintain positive relationships with management, peers, and
  subordinates.
• Excellent verbal and written presentation, communication skills along with fluency in
  English are necessary. Highly motivated, results driven with unyielding predisposition
  to detail and accuracy.
• Demonstrate increasing levels of TMF responsibilities.
• Possess high degree of initiative and the ability to work independently.

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