Associate TMF Specialist

Overview:

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. 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. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring an Associate TMF Specialist to join our global team in the EU! Our Clinical Operations Team 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!

• Contributes to ensuring high quality TMF content in accordance with Rho SOPs. This requires daily quality control (QC) activities to include document quality, indexing, and metadata accuracy checks to ensure ongoing compliance and inspection readiness
• Promotes standardization, consistency, and accuracy of filing by ensuring TMF content aligns to requirements and filing guidance as specified in the study specific TMF Index and TMF Management Plan
• Issues queries to internal and external study team members with oversight from TMF Leads in response to document quality issues identified during the QC workflow
• May support cross-functional periodic TMF quality reviews by providing essential reports and document listings
• May support TMF Leads in resolution of quality findings resulting from periodic TMF quality reviews
• May assist TMF Leads and the project team in preparation for internal/external audits
• May assist TMF Leads and the study teams in completing requirements for closing out the eTMF when the study is complete
• Attends and contributes to study team meetings as needed and complete study specific training for assigned studies

• Knowledge of essential and supporting clinical trial documentation preferred
• Electronic TMF system experience preferred, specifically with Veeva Vault eTMF
• TMF Reference Model exposure preferred
• Familiarity with current ICH GCP guidelines and applicable regulations
• Ability to maintain confidentiality
• Ability to work well with all levels of staff, builds constructive and collaborative relationships
• Maintains a professional demeanor and is a team player
• Excellent oral and written communication skills
• Strong attention to detail with the ability to maintain high level of accuracy
• Must have excellent computer skills, including experience in Word, Excel and PowerPoint, with ability to quickly and efficiently learn new eTMF and other computer systems
• Independently motivated with strong organization skills and problem solving ability
• Excellent organizational and time-management skills, with the ability to manage multiple competing priorities within various clinical trials
• Decisive and objective problem-solving ability

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, and generous paid time off, holidays, parental leave and bereavement leave.

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.

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