Trial Master File Lead (Clinical) - Remote - US shift

Trial Master File Lead

Job Description

Responsibilities:

• Responsible for the comprehensive review and approval of TMF/eTMF Management plans.

• Complete the build/set up of the electronic TMF system for each study, as well as the maintenance activities related to system ownership.

• Perform user account management functions and provide access to internal and external users including ensuring accuracy and consistency in basic user access, proof of training requirements, connectivity issues, and system functionality.

• Review and provide feedback to TMF Operations staff and study team members on trends and compliance with GCP/ICH and standard operating procedures. as appropriate to ensure TMF meets completeness, quality, and timeliness.

• Review output of scheduled periodic and ad hoc spot checks performed to assess the contemporaneousness of the TMF and provide feedback to the management of the TMF Operations group, study Project Manager or designee, and senior management, as applicable.

• Provide project teams with TMF quality information, guidance, training, and support based on applicable quality documents and corporate directives.

• In conjunction with management, support TMF audit and inspection readiness by conducting TMF/eTMF content quality reviews at defined time points, collaborating with internal team members, providing periodic updates, ensuring that FHI Clinical privacy and security standards are met and adhered to, and verifying study specific information on a regular basis.

• Assist with maintaining up-to-date study status tracking and other tracking tools, as assigned.

• Initiate and ensure the completion of the TMF Plan.

• Manage the archive and destruction of the project-related deliverable content for services which could include collaborating with other departments and internal and external project team members, conducting quality control reviews of the archive materials, and ensuring accuracy and consistency of archive procedures.

• Define and implement organizational process improvement activities to increase efficiencies and provide recommendations for remediation, as required.

• With oversight, participates in the development of, and reviews TMF-related Standard Operating Procedures (SOPs) and other quality documents.

• Interview and conduct technical proficiency testing of potential TMF Operation group candidates. • Train and mention TMF Specialists and TMF Coordinators. Meet with staff regularly to ensure that studies are on target to meet TMF-related completeness, quality, and timelines.

• Provide back-up support to the management roles within the TMF Operations group.

• Any other duties and responsibilities as may be assigned from time to time.

Knowledge, Skills, and Abilities:

• Ability to present materials and represent the TMF Operations group in client audits.

• Strong understanding of the industry wide TMF Reference Model

• Demonstrated ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results.

• Ability to work well with people and establish effective relationships across all levels of the organization. Strong computer skills (MS Office), SharePoint, and Acrobat.

• Ability to format and publish large documents and create and maintain tracking systems and spreadsheets.

• Ability to coordinate review and finalization of documents with multiple stakeholders.

• Aptitude to learn additional software programs and databases quickly.

• Ability to handle multiple tasks simultaneously; manage and prioritize workload in a proactive manner.

• Ability to work effectively under pressure of deadlines.

• Demonstrated ability to make decisions involving conflicts of interest.

• Excellent attention to detail.

• Knowledge of clinical trial design, execution, and operations.

• Strong ability to audit trial master files.

• Must be able to read, write and speak fluent English.

Position Requirements Education: Bachelor’s degree or its international equivalent.

Preferably in Health, Behavioral, or Life Science related field.

In lieu of a degree, an equivalent combination of education, training, and relevant work experience.

Preferred Job-related Experience: 5+ years of TMF operations experience with FDA, ICH and GCP guidelines.

At least 1 year of prior experience with leading and auditing the quality review efforts of trial master files and a team of individuals in the TMF process activities.

Experience with managing clinical study documents using FDA, ICH GCP guidelines and best practices pertaining to clinical trial document management and archiving.

Prior experience working in a cross-matrix environment.

Experience with an electronic TMF System.