job title: associate tmf specialist (emmes)

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.