Team Lead, TMF Operations

Company: Alimentiv Inc.
Location: San Diego
Posted on: February 22, 2021

Job Description:

Position Title: Team Lead, TMF Operations (Full-time, Permanent)
Position Reports To: Manager, TMF Operations # of Direct Reports: 1-7 Department/Unit Name: Clinical Operations > TMF Operations
JOB SUMMARY: Ensure that all Trial Master Files (TMFs), and associated deliverables, are complete and inspection ready at all times. Oversee the setup, maintenance and close of the TMF on a per study basis. Accountable for the complete and accurate TMF oversight through documentation of quality, consistency and timely filing across all assigned clinical trials, consistent with the TMF specifications. Responsible for ensuring processes are in accordance with corporate and industry best practices as well as all applicable regulatory requirements and guidelines. Lead, coach and mentor a team of employees. Communicate and promote department goals and practices. Interact with stakeholders in a way that promotes a positive working atmosphere and encompasses a professional and helpful attitude. AREAS OF RESPONSIBILITY: Service Delivery

• Lead the setup of the study in the electronic repository
• Participate in TMF oversight discussions with stakeholders to optimize TMF management technology, processes and standards
• Monitor the completeness and quality of TMF content for assigned studies and provide recommendations on improvements, guidance, as needed
• Oversee documentation flow within projected timelines and determine course of actions to prevent and remediate delays and errors
• Provide support for study TMF-related queries (including those from file reviews and audits) and in the preparation of appropriate responses
• Assess and report on the progress of the TMF to stakeholders
• Communicate and interact with study team members from study set up through to TMF lock/decommission
• Conduct periodic TMF quality reviews and liaise with appropriate stakeholders to encourage resolution of TMF findings
• Perform day-to-day study TMF management activities for specific studies, as needed Team Management and Engagement
  • Focus team members on the tasks at hand and/or the internal/external customer requirements.
  • Create an environment oriented to trust, open communication and creative thinking.
  • Facilitate & support professional development through discussions with staff both at the annual appraisal and regular intervals throughout the year .
  • Motivate, inspire, guide and coach team members, identify areas for new training or skill checks, and develop strategies to promote team member adherence to company procedures, standards and performance goals.
  • Facilitate problem solving and collaboration and intervene when necessary to aid the team in resolving issues.
  • Assist management with hiring and new team member training. Department Operations Support
    • Prioritize TMF work distribution across all studies, in accordance with study activities and milestones.
    • Involve other functional groups, as applicable, to develop, optimize and maintain TMF guidance documents, tools and training materials.
    • Prepare and/or determine standards for organization's TMF best practices and lead/participate in TMF process improvement initiatives.
    • Maintain up-to-date knowledge of the TMF Reference Model, industry best practices and regulatory considerations.
    • Provide education, feedback and guidance to stakeholders to build knowledge and awareness of good document management practices for clinical trials.
    • Propose and collaborate on department initiatives and strategies.
    • Chair department meetings to--provide an opportunity for team to share information, make announcements, or engage in--departmental--decision-making.
    • Support corporate change management initiatives, communication plans and other engagement strategies.
    • Participate in new employee orientation, as needed.
    • Represent department on company improvement initiatives, committees, work streams and governances.
    • May represent the department at business development, sponsor and/or other professional meetings.
    • Travel domestic and/or international to other office locations and/or for training opportunities.
      QUALIFICATIONS: Applicants should have a minimum of a College Diploma/Degree and 3-5 years of relevant experience. Certificate/Certification in Clinical Trial Management or Clinical Research is preferred. Familiarity with the Trial Master File Reference Model and a demonstrated understanding of records management best practices is required. Previous supervisory/line management experience, and coaching/mentorship abilities are considered an asset. The successful candidate will possess exceptional written and verbal communication skills. Additionally, they will be skilled in adapting to new computer/software programs including eTMF and other clinical trial management systems. Lastly, the Team Lead, TMF Operations will be skilled in negotiation, conflict resolution, and working across different cultures.

Keywords: Alimentiv Inc., San Diego , Team Lead, TMF Operations, Other , San Diego, California