Team Lead, TMF Operations
Company: Alimentiv Inc.
Location: San Diego
Posted on: February 22, 2021
Position Title: Team Lead, TMF Operations (Full-time,
Position Reports To: Manager, TMF Operations # of Direct Reports:
1-7 Department/Unit Name: Clinical Operations > TMF
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
- 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
- Provide support for study TMF-related queries (including those
from file reviews and audits) and in the preparation of appropriate
- Assess and report on the progress of the TMF to
- 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
- 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
- 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
- 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
- Prepare and/or determine standards for organization's TMF best
practices and lead/participate in TMF process improvement
- 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
- Chair department meetings to--provide an opportunity for team
to share information, make announcements, or engage
- 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
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