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TMF Operations Manager

1 day, 20 hours ago
Anywhere
Full-time
Senior
Operations Manager
Project and Program Management
Apply Now
Definium Therapeutics

Definium Therapeutics

Definium Therapeutics is dedicated to advancing psychiatry by developing accessible treatments that leverage the therapeutic potential of psychedelic medicine, guided by scientific rigor and a commitment to addressing the root causes of mental health i...

Health Care Providers & Services
51-250
Founded 2019
View All Jobs 18

Description

  • Own the strategic oversight, operational management, and continuous improvement of the Trial Master File across clinical studies from eTMF build through archival.
  • Develop the TMF Plan and index, manage document distribution metrics, handle user access, and escalate TMF issues as needed.
  • Lead TMF quality review activities, including ongoing completeness checks to ensure required documents are accurately filed, complete, and accessible.
  • Serve as the liaison to CRO TMF teams, review KPIs and reports, and provide guidance on documentation requirements and escalation strategies.
  • Identify eTMF trends, misfiled documents, inconsistencies, discrepancies, and gaps, and implement corrective actions to prevent recurrence.
  • Lead the creation and delivery of training for study teams on document classification, key attributes, and query resolution.
  • Serve as the TMF subject matter expert for the study team and vendors, supporting execution of the expected document list and expected numbers.
  • Provide regular TMF status updates in internal and external study team meetings.
  • Prepare for and support TMF audits, including documentation preparation and resolution of audit findings.
  • Support SOP and work instruction development and review related to clinical document management, and assist with inspection readiness activities such as storyboards and regulatory dossier preparation.

Requirements

  • Bachelor's degree or equivalent combination of education and experience in a science- or health-related field.
  • Minimum 5 years of clinical operations experience, including global trial experience.
  • Thorough knowledge of the CDISC TMF Reference Model, ALCOA+ standards, Good Documentation Practices, and FDA/EMA/MHRA regulations.
  • Experience with eTMF systems such as Medidata RCM or Trial Interactive, including training materials, SOPs, UATs, and change control management.
  • Ability to independently engage in cross-functional interactions with internal and external stakeholders.
  • General knowledge of clinical trials and basic principles of trial planning and execution.
  • Prior participation in regulatory health inspections such as FDA, EMA, or MHRA is preferred.
  • TMF SME experience in inspection preparation activities, including mock inspections.
  • Experience balancing CRO TMF SOP requirements with internal expectations while maintaining rigorous quality standards.
  • Technical experience creating data visualizations, data summaries, and project management tools in MS Excel and Smartsheet is preferred.

Benefits

  • Starting base pay range of $122,205.00 to $144,400.00.
  • Eligibility for additional compensation, including bonus and equity.
  • 100% paid medical, dental, and vision coverage for employees and dependents.
  • 401(k) program with company match and vesting after the first month.
  • Flexible time off.
  • Generous parental leave.
  • Additional fringe perks.

Interested in this position?

Apply directly on the company website

Apply Now

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