Manager, TMF

A leadership role within TMF Operations responsible for end-to-end delivery of TMF services, collaborating with internal and external customers and ensuring staff deliver high quality, timely service in line with corporate procedures, regulatory requirements, all applicable guidelines and industry best practices.

Responsible for personnel management including but not limited to hiring, managing staff performance and development, study resource allocation and staff engagement and retention.

Support the alignment of activities and objectives of the TMF Operations groups with the organization’s core values, strategy and vision.

Service Delivery Oversight

• Ensure TMF deliverables for projects assigned meet/exceed project/study team expectations regarding quality, timeliness and completeness.
• Provide input and guidance on escalated TMF issues with consideration of the applicable level of risk.
• Collaborate with other clinical teams and functional leadership to manage project related challenges and to achieve exemplary customer service.
• Partner with internal and external stakeholders and lead working groups to address procedural gaps and optimize TMF Management technology, processes, and standards.
• Serve as a subject matter expert on TMF Management Best Practices to ensure management of TMFs in a consistent and standardized manner.
• Provide education, feedback, and support to study teams to build knowledge and awareness of good document management practices and apply lessons learned across studies.
• Support Revenue Management during change orders that require adjustments to TMF hours due to a change in study scope/services.

Staff Management & Engagement

• Monitor and review performance management of direct reports; conduct regular one-to-one meetings to discuss performance employing coaching and mentoring skills, constructive criticism, and help with goal setting and management through empowerment and motivation techniques.
• Hiring and oversight of staff onboarding plan.
• Study resource allocation (primarily within product line) in accordance with study scope and milestones.
• Evaluate training needs for assigned staff.
• Establish and track performance metrics by role.
• Assist staff with establishing priorities and timelines across multiple projects.

Corporate Operational Management

• Create a positive working environment oriented to trust, open communication and creative thinking.
• Propose and collaborate on department goals, initiatives and strategies.
• Facilitate TMF oversight discussions to create solutions to address business and operational challenges.
• Ensure operational efficiency and excellence by facilitating review cycles on current processes for continuous improvement.·
• Support with project costing and management of expected versus actual budgets
• Consult on the department budget and determine staff needs for training and travel

Other Responsibilities

• Represent department on company improvement initiatives, committees, work streams and governances.
• May work with other departments and analysts on special projects to ensure company end to end processes and technologies are efficient and effective, work seamlessly together and deliver improved customer value.
• May support Business Development activities related to TMF Management.

Qualifications

• A minimum of a college diploma/degree and 7-9 years of relevant experience.
• Familiarity with the Trial Master File Reference Model, comprehensive understanding of management of TMF content within an electronic platform, good document practices and knowledge of ICH GCP and relevant regulations for the conduct of clinical trials.
• Previous coaching/mentorship and supervisory/line management experience is preferred.

Working Conditions

• Home-based.