Clinical Operations Specialist

3 days ago


Bengaluru, Karnataka, India EMMES Full time

About Emmes Group

We are a clinical research organization dedicated to advancing medical discovery and improving patients' lives. Our team of experts is passionate about building a better future for us all.

Overview

We were founded over 47 years ago as Emmes, a leading provider of clinical research services to the US government. Today, we continue to expand our capabilities in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Job Description

The Associate TMF Specialist will be responsible for uploading and indexing TMF documents in eTMF or filing, organizing, and maintaining documents in paper TMF with a strong focus on ensuring adherence to SOPs, Project, and Corporate guidelines, as well as ICH GCP TMF guidelines.

Responsibilities

  • Act as an SME on eTMF application features related to TMF Operations, TMF processes, document identification, filing, and adhering to the TMF Plan Index created by Lead Senior TMF Specialist.
  • Contribute to the identification of expected documents based on filed documents and ensure that 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.
  • Contribute to SOPs, Project, and Corporate guidelines, work instructions, and templates 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.
  • Acquire expertise in eTMF applications used for studies where sponsor eTMF is chosen as TMF repository.
  • Contribute to streamlining processes and implementing automation such as VBA macros, Robotic Process Automation (RPA), system integration, Artificial Intelligence (AI), and Machine Learning (ML).
  • Perform tasks within eTMF application to maintain the lifecycle of the TMF, including EDL maintenance, reports, and metrics.

Qualifications

  • Bachelor's degree required, preferably in a 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.
  • 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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