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 a Senior TMF Lead 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!

The Senior TMF (Trial Master File) Lead helps to drive the success of each study specific TMF from study start-up through study close-out. This position contributes to the oversight, management, and success of the overall TMF business process eTMF solution and study TMFs with the goal to ensure high quality and compliant TMFs. Responsible for Quality Control of both standard and complex global TMF content collaborating with functional SMEs to address compliance challenges.

• Leads TMF setup, maintenance, and close-out activities, which may include complex, global studies and programs
• Promotes consistency and accuracy of filing by identifying program or study specific trends, including trends that span across regions via TMF key performance indicators, data analysis tools, and reporting; Uses expert TMF knowledge to develop and propose planned mitigation and actions needed to resolve non-compliance, escalating as needed to clinical trial operations leadership
• Collaborates with the Project Lead to identify and address complex quality, compliance, and completeness needs throughout the study lifecycle, assessing and assigning TMF priorities and providing expert guidance as needed in response to study and Client needs
• Responsible for ensuring high-quality TMF content following Rho SOPs. May require query management and periodic, individual quality control (QC) activities at peak times of document submissions to include document quality, indexing, and metadata accuracy checks to ensure ongoing compliance and inspection readiness, including confirming that the content collectively provides an accurate reconstruction of the trial
• Supports the development and usage of TMF reports for regular communication of KPIs to functional leads and clinical trial operations leadership; Supports the collaboration with clinical trial operations leadership to address compliance, quality, or completeness issues
• Supports development, updates, and finalization of new and existing procedural documentation and internal and external training and resources specific to global TMF activities
• Provides TMF training to study team, Client, and vendor users; Identifies training gaps and provision training as needed to improve skillset and core competency
• Leads project team in preparation for internal/external audits
• May lead external qualification audits
• Responsible for identifying and escalating study follow-up and action needed by TMF Specialists to support ongoing quality cleanup activities, including aging query follow-up and metadata and consistency updates
• May be responsible for providing guidance and oversight to TMF Specialists on ongoing cleanup and follow-up activities
• May lead global TMF migration activities
• Serve as a TMF Reference Model expert, how it applies to the index on a global scale, and how those two items relate to each other; stays informed of industry trends
• May support system upgrades and change controls by performing user acceptance testing, which may include contributing to test scripts and user requirements
• Manages completeness accuracy for studies by monitoring TMF content submissions in comparison to the study-specific TMF index, using extensive, global TMF knowledge to guide and assist the study team in ongoing eTMF and index updates to ensure the TMF accurately reflects the evolving documentation requirements of the study
• May manage expected document lists and perform placeholder maintenance in collaboration with the study team, including adding new placeholders when necessary, removing excused items, adding and reconciling events, updating milestones, and managing priority settings where relevant
• Provides excellent customer service to internal and external clients in a timely and professional manner
• Responds to email and other communication requests in a timely fashion using a variety of methods, including but not limited to email, instant messaging, and other communication tools
• Takes initiative to complete project-specific responsibilities with minimal supervision
• Other duties as assigned

Direct Management Responsibilities:

• No direct responsibilities; may provide mentoring and feedback to junior level employees.

Education and Experience:

• BA/BS required, advanced degree with scientific or health care training preferred
• A minimum of 8 years’ experience working in a clinical research/clinical development industry to include experience in managing eTMF projects
• eTMF experience required, including supporting process development and primary responsibility for TMF set-up, study start-up, maintenance and close-out
• PhlexTMF or Veeva Vault eTMF experience preferred
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• Demonstrated ability to train and mentor TMF team members
• Advanced critical thinking skills to identify effective and efficient solutions for complex problems and to quickly grasp new practices and derive opportunities for improvement
• Expert knowledge of the TMF Reference Model and how it applies globally
• Advanced ability to interpret a study specific TMF index
• Extensive knowledge of FDA & ICH/GCP regulations and guidelines and country specific documentation and record management standards
• Ability to articulate data insights to study team members and influence decision making
• 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
• Ability to work independently, prioritize and work with a matrix team environment is essential
• Decisive and objective problem-solving ability
• Ability to quickly adapt to evolving needs and priorities

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 in English