TMF Specialist

1 week 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

Similar Roles

Private Market Specialist

Mercer Advisors 251-1K Capital Markets

Mercer Advisors is hiring a Private Market Specialist to provide operational support for its Private Investments team in servicing client needs and ensuring smooth execution of private investment activities.

CRM Salesforce
32 minutes ago

Entry-Level Automotive Detailer / Lot Attendant Post Production

Carvana 10K-50K Automotive

Carvana is hiring entry-level automotive team members to inspect, detail, move, and photograph vehicles in its high-tech reconditioning centers before they reach customers.

1 hour, 17 minutes ago

Payment Network Analyst II (Card Networks)

Pathward 251-1K Diversified Financial Services

Pathward is hiring a remote-friendly payment networks operations specialist to implement, support, and maintain program setups and network-related processes for financial products.

1 hour, 17 minutes ago

Specialist II, Facilities, Property Operations

Carvana 10K-50K Automotive

Carvana is hiring a Specialist II, Facilities, Property Operations to support facility maintenance and property operations across an assigned portfolio as the company continues to scale nationally.

1 hour, 32 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers