Overview:
nEmmes Group: Building a better future for us all.
nEmmes 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.
nWe 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!
nPrimary Purpose
nThe 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.
nResponsibilities:n
- Acts as an SME on eTMF application features related to TMF Operations, TMF processes, document identification/filing.
- nAdheres 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.
- nContributes to the identification of expected documents based on filed documents.
- nEnsures 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.
- nContributes 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.
- nSupport implementation of features of Veeva Vault eTMF system in conjunction with the Clinical Systems Manager.
- nAcquires expertise in eTMF applications used for studies where sponsor eTMF is chosen as TMF repository.
- nContributes to streamlining the processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI)/Machine Learning (ML).
- nPerform tasks within eTMF application to maintain the lifecycle of the TMF (e.g., EDL maintenance, reports and metrics, etc.)
- n
nQualifications:n
