Position Summary:
The Director, Records Management, is responsible for leading the Records Management function for clinical trials conducted by Precision’s Clinical Solutions. Responsibilities include the development and implementation of strategies for managing, processing, and storing clinical documents collected or created during clinical research. The Director has accountability for the oversight and management of the electronic Trial Master File (eTMF) system and for ensuring proper business continuity planning.
Essential functions of the job include but are not limited to:

Primary Responsibilities:

• Lead the Records Management function to support Clinical Research.
• Manage and oversee the Records Management team, including hiring, training, and performance management.
• Manage, provide direction, and maintain strong relationships with Precision’s Clinical Systems team, TMF vendor(s), and IT to drive resolution of issues and remediation activities.
• Develop and implement TMF processes and procedures, and TMF-related training materials that adhere to regulatory requirements and industry best practices.
• Develop and maintain strong relationships with internal stakeholders, including acting as a subject matter expert for TMF operations and requirements.
• Collaborate with cross-functional teams to ensure TMF completeness and accuracy throughout the trial lifecycle.
• Manage the quality control of TMF documents according to GCP and regulatory requirements from study start-up through inspection readiness and archival.
• Develop and establish TMF Key Performance Indicators (KPIs) globally for internal staff, contractors, external vendors, and other stakeholders.
• Monitor and report TMF metrics to senior management, identifying areas for process improvement and implementing changes as needed.
• Oversee teams that providing monitoring and reporting on TMF completeness and readiness to study teams.
• Serve as functional TMF inspection lead for regulatory inspections, providing relevant documents and information as required.
• Identify root cause of performance issues, determine the appropriate remediation, and implement solutions as required.
• Keep informed of regulatory changes and industry best practices related to TMF operations and coordinate with stakeholders to implement continuous operational excellence.
• Collaborate with Clinical Systems team to manage eTMF system configuration changes in accordance with established change control processes and monitoring the impact of configuration changes to optimize performance.
• Provide support and input for general Records Management practices across the Precision organization.

Qualifications:

Minimum Required:

• Bachelor’s Degree
• 10+ years of clinical research experience, with at least 5 years in TMF operations and oversight.
• Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) and industry best practices for TMF operations.
• Experience with electronic Trial Master File systems (e.g., Veeva, Trial Interactive) and related technology platforms.
• Proficient knowledge of DIA TMF Reference Model.
• Demonstrated strong governance management in a matrixed setting, including the abilities to inform strategic decisions, to facilitate and negotiate through complex strategic decisions, to communicate with executive leadership, and to influence without authority when necessary.
• Solid foundation in data governance principles and experience managing large data sets.

Other Required:

• Knowledge of clinical trial operations and processes.
• Excellent planning, organizational and time management skills, including the ability to support and prioritize multiple projects.
• Demonstrated leadership skills to drive results to achieve optimal outcomes.
• Experience in managing a team and providing leadership to drive performance.
• Excellent communication skills and ability to collaborate with cross-functional teams.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Working knowledge of ICH-GCP guidelines and major Health Authority regulations as they pertain to the operational aspects of clinical studies and the management of TMF content.
• Proven ability to collaborate in a team environment and work independently.
• Proven ability to establish productive working relationships across large organizations, communicate well at all levels, and to work collaboratively in a highly matrixed reporting environment to build strong partnerships.

Preferred:

• Master’s Degree preferred
• Proven ability to collaborate in a team environment and work independently.
• Excellent oral and written communication skills
• Must be a team-player, punctual and reliable, dependable, and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.