Position Summary

The Senior Manager, TMF Specialist is responsible for the day-to-day management of Odonate’s Trial Master File (TMF), including oversight of the review and approval of TMF documents and generation of reports to measure completeness, accuracy and timeliness of the TMF. This role has a strong focus on ensuring that document management operations are performed with adherence to standard operating procedures (SOPs) and ICH GCP/regulatory guidelines and ensuring the TMFs are inspection ready at all times.

Essential Duties and Responsibilities

  • Prepare the study specific TMF plans and ESAPs and insure these are current throughout the study and finalized at study completion
  • Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed
  • Analyze TMF processes for efficiency, suggest and make improvements
  • Monitor and identify study-specific TMF trends and communicate to department leads
  • Conduct TMF educational workshops/trainings
  • Manage TMF projects, assist with overall change management, and build collaborative relationships with various teams
  • Assist with inspection/audit related activities (e.g., preparation, correction action plans)
  • Perform eTMF business administrator responsibilities to include programming of Essential Document Lists (EDLs), country intelligence updates and document type updates
  • Perform quality control of documents submitted to the TMF using the established acceptable criteria, as needed
  • Ensure clinical trial documentation is consistent with TMF specifications, applicable to SOPs, ICH/GCP guidelines and other regulatory agency requirements
  • Address TMF questions pertaining to how documents are filed, and user questions related to the TMF system
  • Maintain up to date knowledge of the TMF Reference Model 3.0, industry best practices and regulatory considerations as applicable to the job duties
  • Assist with relevant projects as needed

Qualifications

  • Bachelor’s Degree in a Life Sciences discipline required
  • Minimum 3 years of relevant clinical research and TMF experience required
  • Previous experience in Veeva Vault TMF preferred
  • Strong knowledge of ICH and FDA GCP guidelines related to clinical document management
  • Understanding of the clinical trial process, experience in handling clinical trial related documents required
  • Ability to attain and maintain a working GCP knowledge
  • Demonstrated ability to achieve high performance goals and meet deadlines in a fast- paced environment
  • Strong organization skills with outstanding attention to detail and follow through
  • Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities while exhibiting the highest level of customer service
  • Demonstrated proactive approaches to problem-solving with strong decision-making capabilities
  • Must be fully proficient in MS Office Suite, WebEx and internet research

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