Company is hiring a TMF Classifier I to manage document classification and the electronic Trial Master File (eTMF) for clinical studies. You will be responsible for maintaining the TMF in a state of audit readiness, processing essential artifacts, and managing operational issues related to the TMF.

What You'll Do

Manage electronic Trial Master Files (eTMF) for clinical studies in accordance with TMF processes.
Perform document classification under Smart Inbox (when applicable), ARC review, and document deletion.
Maintain the TMF in a state of audit readiness by performing visual quality checks and audit ready checks on documents.
Process and track final essential artifacts required throughout all phases of the study per SOPs, GCP, and ICH guidelines.
Manage the identification of operational issues and resolutions related to the TMF.
Prepare the TMF for QA or Sponsor audits and implement corrective actions from audit reports.
Participate in Internal Audits and Client Audits as per study requirements.
Collaborate with all members of BP and S to ensure overall client satisfaction.
Participate in business improvement initiatives to drive quality, productivity, and continuous improvement.
Attend internal or external study team meetings as required.

What We're Looking For

Bachelor’s Degree with a Life Sciences/Business focus.
Minimum 6 months to 12 months experience working in a clinical research environment.
Clear understanding of GCP and ICH guidelines.
Knowledge of Regulatory/Clinical document requirements.
Knowledge of Microsoft Office products, web based applications, and Adobe Acrobat Standard, plus ability to apply related knowledge regarding scanning and other software programs.
Excellent interpersonal skills.

Nice to Have

Master’s Degree with a Life Sciences/Business focus.
Equivalent experience within clinical research environment of a minimum of 6 months to 12 months, may be substituted for education requirements.
Experience working in clinical electronic systems.