Job Description

Overview: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. Were 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 PurposeThe Associate TMF Specialist is primarily responsible for uploading and indexing the TMF documents in eTMF or filing, organizing and maintaining documents in paper TMF with a strong focus on ensuring that routine operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines. Responsibilities:

• Acts as an SME on eTMF application features related to TMF Operations, TMF processes, document identification/filing.
• Adheres to the TMF Plan/Index created by Lead/Senior TMF Specialist and ensures that TMF document collection is in line with the TMF Plan/Index.
• Contributes to the identification of expected documents based on filed documents.
• 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.
• Contributes to SOPs (Project and Corporate), company guidelines, work instructions and templates (e.g., 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 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., EDL maintenance, reports and metrics, etc.)

Qualifications:

• Bachelor's degree requited, preferably in scientific discipline.
• Incumbent typically will possess 0 to 3 years of Clinical Operations/Filing documents experience in TMF Operations.
• Knowledge of filing procedures and eTMF application is mandatory.
• Experience in Veeva 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, technical background, integrity.
• Good 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.
• Possess high degree of initiative.

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