SanDiegoRecruiter Since 2001
the smart solution for San Diego jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Supplement Your Warehouse Income - Grocery Shopper
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Placentia
Posted on: 03/5/2021

Set Your Own Schedule - Shop and Deliver Groceries
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Rowland Heights
Posted on: 03/5/2021

Make Up To $20/Hour - Deliver With Postmates
Description: Postmates has the largest
Company: Postmates
Location: Yucaipa
Posted on: 03/5/2021


Shopper - Flexible schedule, up to $22 an hour
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Rowland Heights
Posted on: 03/5/2021

Account Executive
Description: At A Glance ul Full-time Account Executive role ideal for self-motivated sales professionals who enjoy being on the go.Opportunity for career mobility and growth for individuals who have a passion to (more...)
Company: SPECTRUM
Location: Santee
Posted on: 03/5/2021

Set Your Own Schedule - Shop and Deliver Groceries
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Yucaipa
Posted on: 03/5/2021

Supermarket Shopper & Delivery
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Placentia
Posted on: 03/5/2021

Premier Banker - Yorba Linda & Rose
Description: Job Description Important Note: During the application process, ensure your contact information email and phone number is up to date and upload your current resume when submitting your application for (more...)
Company: Wells Fargo
Location: Placentia
Posted on: 03/5/2021

Part Time Delivery Job - Earn up to $22/hr
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Placentia
Posted on: 03/5/2021

Work in Retail? Earn Extra Cash Delivering Groceries
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Placentia
Posted on: 03/5/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Diego RSS job feeds