Job Description

Join us in redefining what it means to work for a CRO.

When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. We’re not your typical CRO, and we’re not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you’re a data wizard, analytical genius, project mastermind, or any other role, you’ll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.

You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

We are currently hiring a TMF Specialist to join our team in Warsaw, Poland! As a TMF Specialist, you will have the opportunity to ensure TMF (Trial Master File) completeness and compliance of clinical trial records from trial start-up through trial close-out. You will maintain inspection readiness and support project teams in accurate trial reconstruction aligned with regulatory requirements, the industry standard model, and established TMF processes. You will also be responsible for quality control of standard and complex TMF records, partnering with project teams and functional subject matter experts to address quality gaps and support continuous compliance.

Our clinical operations and TMF teams will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Key Responsibilities:

For TMF Management and Oversight:

• Perform administrative TMF set up and maintenance tasks, such as milestone updates, new site additions, and ongoing study, country, and site level updates
• Support TMF maintenance in accordance with Rho SOPs, and study-specific TMF Management Plans and Indices.
• Support ongoing user access management

For TMF Completeness and Reconciliation:

• Upload and index TMF content within Rho or client systems
• Support low complexity TMF reconciliation and cleanup activities

For TMF Quality Control, Quality Review, and Compliance:

• Perform TMF QC per SOPs, TMF standards, and applicable regulations: check artifacts for visual quality, classification, and metadata accuracy
• Issue queries for discrepancies and assist in follow-up
• Escalate unresolved quality issues to TMF Leads

For TMF Audit and Inspection Readiness:

• Support TMF Leads in locating TMF records for audits and inspections
• Promote standardization and accuracy of filing in line with the study‑specific TMF Index and TMF Management Plan
• Identify and escalate potential study‑specific documentation updates to support accurate filing and ongoing inspection readiness

For TMF Training and Mentoring:

• Provide guidance to internal study teams on filing, metadata completion, and classification best practices at the direction of TMF Leads

For TMF System Management:

• Escalate TMF platform issues reported by TMF users to TMF Leads
• Support user acceptance testing for TMF system upgrades when requested
• Support basic troubleshooting for TMF system issues under guidance

Requirements

• Bachelor’s Degree, preferably in life sciences or public health, as well as at least 1-2 years experience working in the clinical trials industry, including exposure to a variety of TMF records
• Familiarity with TMF Reference Model and TMF Indexes, electronic TMF systems (Veeva Vault, PhlexTMF, Kivo, etc.), clinical trial phases and essential records, drug development process, ICH-GCP guidelines, and federal regulations
• Ability to interpret a study specific TMF index to guide record classification and metadata requirements
• Strong Communicator: Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s.
• Committed to Quality: Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome.
• High-Character: Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust. We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another.
• Critical Thinker: Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience. We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions.
• Agile and Adaptable: Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment. We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

A few more things to know about us:

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

Please submit your CV/resume in English. We look forward to hearing from you!

Benefits

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.