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TMF Quality Manager

New Jersey All, New Jersey

Post Date: 07/19/2017 Job ID: JN -072017-19565 Industry: CTA - Clinical
  • Single Point of Contact to the Therapeutic Areas (TA)/Clinical Trial Team for TMF related questions and serves as Subject Matter Expert on TMF Quality Control
  • Maintain documentation of appropriate oversight of all external partner s work specific to document management within the TMF
  • Responsible for optimizing, maintaining, and rolling out TMF Quality Control training mechanisms
  • Translate trial information, processes and regulations into TMF documentation
  • Responsible for conducting specified quality controls on some essential clinical documents according to established processes
  • Track progress to key quality indicators (KQIs)s, and overall compliance to TMF processes and regulations
  • Oversight of TMF QC Specialists and monitor QC performed by the TMF QC specialists on assigned trials
  • Provide training/mentoring to the TMF QC Specialists on TMF processes, reconciliation/QC
  • Maintain documentation of appropriate oversight Of Vendor TMF Technical Quality Control Personnel specific to document management QC within the TMF
  • Single Point of Contact to the CTT for their assigned trials
  • Provide CTT with TMF QC reports and assist with TMF related questions (e.g. TMF Table Of Content)
  • Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutions
  • Proactively pull information during the set-up, execution, and close-out phases from accountable CTT members
  • Participate in CTT meetings as needed, responsible for the training of CTTs on TMF and implementation of best practices within CTTs
  • Monitor the CTT compliance with TMF process within a trial in a timely manner
  • Accountable for generating and managing the TMF Filing plan and TMF QC Reports
  • Contact point to secure access to eTRAC system
  • Serve as Subject Matter Expert on TMF training materials, processes and tools (eg. Clinical Document Management system, user Manuals for eTRAC)
  • Participate and/or may lead some meetings related to TMF processes and trainings (eg TMF QC Compliance Review Meeting)
  • As a TMF QC Management & Oversight representative, may participate in global cross-functional business process performance or clinical development improvement initiatives
  • Participate in the on-boarding, mentoring and training of new staff
Requirements:
  • Bachelor s degree in life science/healthcare is required with minimum 4 years experience in clinical operations and / or clinical systems management
  • Associate degree required with minimum 6 years experience in clinical operations and / or clinical systems management

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