eTMF Administrator

Frontier Science is looking for an eTMF Administrator to join their Data Management team! The eTMF Administrator for Frontier Science will be responsible for the configuration and maintenance of Frontier Science's electronic Trial Master File (eTMF), ensuring that all of our document management operations are being performed with adherence to our standard operating procedures, and regulatory guidelines.

Location: This position will be assigned to the Amherst, NY office location but consideration will be made for a full time remote employee.

Major duties and responsibilities:

  • Serve as the primary point of contact and administrator for the eTMF of Frontier Science, taking primary responsibility for reviewing software up-versions for relevant features and working with project leads on subsequent workflow changes;
  • Configure the eTMF based on organizational SOPs;
  • Provide quality management activities for the eTMF to verify the accuracy and completeness of the eTMF (e.g. QA review and the generation of reports and metrics) to ensure inspection readiness;
  • Ensure the eTMF file structure is in compliance with SOPs and regulatory guidelines, including naming conventions and required metadata;
  • Assist staff in using the eTMF;
  • As a member of the Quality department, support the Quality Management System (QMS) administration including but not limited to updates to documents and SOPs as needed, implementation and tracking of training programs, audit finding resolution and tracking;
  • Writing assignments as necessary in support of eTMF activities;
  • Follow appropriate procedures for system and configuration validation;
  • Other relevant duties as assigned as necessary.

Reports to: Quality Assurance (QA) Specialist II

Controls over position:

The eTMF Administrator will be assigned work by the QA Specialist II, and as needed by other Frontier Science Leadership members in accordance with project needs and deliverables.

Required Qualifications:

  • Bachelor’s Degree in a science or health related industry
  • Proven understanding of GCP regulations and clinical trials
  • Minimum two years’ experience utilizing an eTMF
  • Familiarity with the DIA Reference Model for eTMF structure
  • Proficient with all Microsoft Office programs
  • Familiarity with FDA guidelines
  • Excellent communication skills, both written and verbal
  • Strong attention to detail with the ability to multi-task

Applications will be received through the ADP Workforce Now Career Center using the following link: ADP Workforce Now Frontier Science Career Center.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.