About The Position

This role involves independently owning key operational aspects of clinical trials, including TMF integrity and vendor coordination, while also mentoring junior team members. The Senior Clinical Trial Associate will be responsible for the end-to-end management of the study TMF, leading quality reviews, resolving discrepancies, and drafting study documents with minimal oversight. This position also involves managing clinical supply and lab sample coordination, addressing data reconciliation issues, and representing Clinical Operations in team and investigator meetings. Additionally, the role contributes to shaping training materials and SOPs for the CTA team.

Requirements

  • Bachelor’s degree (BS/BA) or equivalent combination of education and work experience in a science-related field
  • 3–5+ years of Clinical Operations or clinical research-related experience
  • Demonstrated ownership of a TMF or vendor relationship from start to finish
  • Comfortable resolving routine CRO/vendor issues independently before escalating
  • Experience mentoring or informally guiding junior team members
  • Excellent verbal and written communication skills
  • Proficiency with MS Word, Excel, Outlook, and PowerPoint

Responsibilities

  • Own the study TMF plan end-to-end: development, tracking, and archiving of Essential Documents across the trial lifecycle
  • Lead quality reviews of the TMF and resolve discrepancies directly with the CRO
  • Draft and finalize study documents — plans, manuals, CRFs, and patient materials — with minimal oversight
  • Serve as a go-to resource for junior CTAs, providing informal mentorship and process guidance
  • Independently manage clinical supply and lab sample coordination, flagging risks before they escalate
  • Own data reconciliation issues across systems, looping in Data Management only when needed
  • Represent Clinical Operations at portions of team meetings and Investigator Meetings
  • Help shape training materials and SOPs used across the broader CTA team
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