TMF Specialist

3 weeks, 6 days ago
Full-time
Junior
Quality Assurance and Testing
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984

Description

  • Perform TMF setup and maintenance tasks, including milestone updates, new site additions, and ongoing study, country, and site-level updates.
  • Support TMF maintenance in line with Rho SOPs, study-specific TMF Management Plans, and TMF Indices.
  • Manage user access for TMF systems and support ongoing access administration.
  • Upload, index, and reconcile TMF content in Rho or client systems.
  • Perform TMF quality control by checking artifacts for visual quality, classification, and metadata accuracy.
  • Issue queries for TMF discrepancies, follow up on unresolved items, and escalate quality issues to TMF Leads.
  • Support audit and inspection readiness by helping locate TMF records and promoting accurate, standardized filing.
  • Provide guidance to internal study teams on filing, metadata completion, and classification best practices.
  • Escalate TMF platform issues, support user acceptance testing for system upgrades, and assist with basic troubleshooting under guidance.

Requirements

  • Bachelor’s degree, preferably in life sciences or public health.
  • 1-2 years of experience in the clinical trials industry.
  • Exposure to a variety of TMF records.
  • Familiarity with the TMF Reference Model and TMF Indexes.
  • Experience with electronic TMF systems such as Veeva Vault, PhlexTMF, or Kivo.
  • Understanding of clinical trial phases, essential records, the drug development process, ICH-GCP guidelines, and federal regulations.
  • Ability to interpret a study-specific TMF index for record classification and metadata requirements.
  • Strong written, verbal, and presentation communication skills.
  • Attention to detail and commitment to high-quality work.
  • Ability to work collaboratively with honesty, integrity, accountability, and adaptability.
  • CV/resume must be submitted in English.

Benefits

  • Work-life balance and flexibility to support both work and personal life.
  • Opportunity to work at a stable company with financial, workforce, and corporate stability.
  • Supportive, collaborative culture with strong team spirit and a focus on mutual trust.
  • Opportunity for career growth and long-term development in clinical operations and TMF.
  • A workplace that encourages innovation and learning from both failures and successes.

Interested in this position?

Apply directly on the company website

Apply Now

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