Manager, Document Management Full Time

The Manager, Document Management is a management position that supports the Document Management department. This role oversees TMF managers and/or Document Management Associates (DMAs), ensuring essential documents in the TMF are inspection-ready and are being maintained in compliance with regulatory guidelines and Advanced Clinical SOPs. The Manager, Document Management requires both strategic and tactical capabilities, in addition to excellence in business processes and innovation in problem solving. The role has direct reports and manages those individuals regarding work commitments and deliverables, project timelines, quality objectives and resourcing allocations/assignments. The scope of responsibilities includes but is not limited to leadership, personnel development, training and oversight, and execution or support of projects within the TMF function. The Manager, Document Management may serve as a subject matter expert for Trial Master File standards, processes and electronic TMF systems.

Essential Duties and Responsibilities

• Serve as a subject matter expert for TMF related topics, including essential documents, TMF management processes and TMF management systems (domestic and international requirements).
• Support implementation and management of electronic TMF applications and/or upgrades.
• Develop and maintain TMF-related SOPs and related documents (e.g. templates, forms, and other written instructions).
• Develop and maintain key performance indicators related to the management of TMFs.
• Monitor, analyze and use key performance indicators to drive timely completeness and accuracy of TMFs; includes leveraging key performance indicators as a means to identify and drive cross-functional process improvements within the organization.
• Ensure accurate processing and filing of essential documents in the TMF by assigned TMF staff per the current TMF Reference Model structure, SOPs and ICH-GCP guidelines.
• Oversee and ensure proper training of TMF staff and other end users (internal and external) to eTMF system functionality and other TMF-related topics.
• Develop strategies and support direct reports, functional team members and other staff to drive project deliverables to agreed timelines.
• Ensure TMF activities are conducted per client budgets and contracts; manage out of scope requests following internal processes.
• Collaborate with electronic TMF vendors as appropriate.
• Ensure routine distribution of TMF status updates to clinical study teams and senior leadership.
• If required, act as the TMF Manager / Lead on client projects.
• Support department resourcing, hiring, performance management and evaluations, team development, mentoring and training, work assignments and allocations.
• Act as a key stakeholder and point of contact during internal or external audits/inspections, including facilitation of inspector access to TMFs and provision of audit/inspection responses, as required; includes assisting the Compliance & Quality team in audit/inspection preparation activities related to the TMF.
• When appropriate, attend industry conferences to advance TMF-related subject matter expertise.

Qualifications

• Education: A Bachelor’s Degree in healthcare or scientific discipline or equivalent combination of education and experience.

Training: N/A

Certification: N/A

Experience:

• Minimum 4 years professional experience working with clinical trial documentation and a minimum 2 years of experience in a leadership/people management capacity, or equivalent.
• Advanced knowledge of TMF industry standards, including thorough knowledge of all sections of the TMF Reference Model (current version).
• Strong experience and knowledge of electronic TMF applications for major non-proprietary system(s), such as Veeva Vault (strongly preferred), Trial Interactive and Phlexglobal.
• Excellent leadership skills and proven industry experience.
• Excellent communication and presentation skills, including written, spoken and listening skills.
• Ability to work in a fast-paced environment.
• Excellent organizational and problem-solving skills.
• Strong ability to work with individuals across various levels of the organization, as well as individuals outside of the organization.
• Strong computer skills, including Power Point, Excel, Word etc.
• Ability to travel as required, up to 20%.

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.).

Company Description:

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.