Job Summary

The TMF Manager is responsible for overseeing the set-up, maintenance and archival of the Trial Master File (TMF), ensuring a state of inspection readiness throughout the project.

Essential Duties & Responsibilities

• Act as the primary point of contact and subject matter expert for assigned TMF projects.
• Provide training and mentorship to Document Management Associates supporting assigned projects, while overseeing their quality of work.
• Develop the project-specific TMF Plan and TMF Index.
• Process TMF documents in accordance with Advanced Clinical, Sponsor, and industry standards; includes document classification, metadata indexing, and Intake QC review.
• Produce reports of key TMF metrics and overviews of overall TMF health.
• Perform or assign TMF Reviews in accordance with the TMF Plan; includes creating requests for missing documents and following up with users on outstanding tasks.
• Perform the transfer and/or archival of the TMF to ensure closeout.
• Train end users on the use of Advanced Clinical Veeva Vault eTMF and related procedures, including providing guidance and training documentation.
• Attend departmental and project team meetings as required. Attend and present, if required, at project kick-off meetings.
• Produce documents for and participate in, as directed, internal or external audits and inspections, including facilitation of inspector access to TMFs if required.

Qualifications

• Education - Associate or Bachelor’s Degree, or equivalent combination of education and experience.
• Training – On-the-job or professional training in regulatory document collection and review. Demonstrated understanding of the CDISC TMF Reference Model filing structure.
• Certification – None required.
• Experience –
  • Five (5) years industry experience working directly with clinical trial documentation.
  • Experience with Veeva Vault or other eTMF systems strongly preferred.
  • The ideal candidate has excellent organizational and time management skills and strong attention to detail, with an ability to maintain productivity and quality in a time- sensitive regulated environment.
  • Must have ability to balance multiple projects simultaneously. Must possess strong computer acumen including proficiency with Microsoft Office suite and familiarity with clinical trial applications, including those used to manage and archive regulatory content.
  • Possesses knowledge of and demonstrates ability to apply pertinent applicable regulations and guidelines pertaining to essential document regulations (e.g., ICH/GCP).
  • Must possess knowledge of and demonstrate ability to apply pertinent applicable regulations and guidelines including Good Documentation Practice and Good Clinical Practice.

Role Competencies

• Thorough understanding of the skills and knowledge relevant to the function. Successful experience in a variety of complex assignments under normal supervision. Able to lead and guide lower-graded personnel.

• Tailors communication (e.g. content, style, and medium) to diverse audiences. Communicates equally effectively at varied organizational levels. High level of written, presentation, and verbal communication skills.

• Searches for ways, ideas and mechanisms to add value to the customer. Develops services and options to support ongoing customer relationships. Prioritizes customer issues and addresses them accordingly.

• Establishes adequate data gathering and analysis policies and procedures. Challenges assumptions and their underlying logic as well as seeks input form multiple sources to gain a clear and comprehensive understanding of an issue.

• Organizes and executes multiple projects/ tasks. Organizes work flow processes to achieve efficiency. Adapts to situational variables and unexpected changes in circumstances.

• Ensures standardization is applied to all processes- creating, developing, improving, and complying with standards. Proactively identifies process improvement opportunities while taking industry trends and best practices into consideration.

• Understands the needs of others. Adapts style to work effectively with partners, building consensus, trust and respect. Enjoys a genuine collaborative relationship with customers.

• Maintains a focus on key priorities and deliverables, staying resilient in the face of pressure. Uses challenges and new situations as an opportunity to learn and improve. Understands own "facts" and "stories" when in dialogue, and the impact leadership style can have on outcomes.

• Actively listens and learns from others, demonstrating patience and consideration for others' concerns or frustrations. Asks questions for clarification and ensures message is understood. Takes time to digest what is heard before responding.

• Visible, approachable, and accessible. Encourages input and participation from colleagues to solve problems and innovate. Provides correct balance of direction and support to staff and colleagues according to each situation. Understands differences, anticipates areas of conflict and takes action.

• Evaluates and measures current processes. Works with a view of the future, prioritizing work in line with organizational objectives. Improves processes to maximize use of resources.

• Seeks opportunities to develop professional skills and knowledge and encourages team to do so. Supports and directs where appropriate, including recognizing achievements and providing constructive feedback and guidance. Cross-train others to broaden experience and develop potential.

• Translates major new directives into individual performance expectations. Explains and convinces others of the need for adaptation and change of policies, structures, and methods.

• Is comfortable facing issues with team members quickly and directly. Is willing to choose an approach that has not been tried before, or a leadership style that feels less comfortable if the situation demands it. Takes personal risks regularly and is not afraid to express bold opinions if the intention and motive is good.

• Consistently reflects the REAL values and inspires team to live and work by these values.

This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).