Sr. TMF Specialist in Bernards, NJ at Apex Life Sciences

Date Posted: 6/13/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Bernards, NJ
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    6/13/2018
  • Job ID:
    858400

Job Description


Duties

  • Participates in electronic QC and indexing of TMF documents as required.
  • Utilizes TMF tools and technology to accomplish tasks without supervision.
  • Proficient in TMF management and can train others.
  • Leads the compilation of the TMF Management Plan and TMF Index in association with the TMF Owner and CROs. Leads the development of TMF technology and tools to accomplish tasks.
  • Regularly trains others on TMF process and provides input on overall training strategy.
  • Participate in policy/procedure development and drafting.
  • Manage HelpDesk queries through to resolution within appropriate timeframes.
  • Serve as TMF SME to study teams and functions.
  • Ensure that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements.
  • Ensure the Trial Master Files are inspection ready.
  • Ensure Trial Master File study specifications are in alignment with program strategy and milestones. Develop consistent setup and maintenance of Trial Master File requirements, processes and program. Ensure that documentation flow for Trial Master File documents meet the required timelines and intervene with action plans and follow up as appropriate.
  • Act as the point of contact for audits/inspections related to the Trial Master File processes and activities and assist with the development of corrective action plans related to Trial Master File findings.
  • Review data quality outputs and audit outputs to identify trends per study and across programs.
  • Develop metrics for performance tracking and document trends for improvement processes of Trial Master File reviews.
  • Manage study setup in the eTMF System on a timely basis for studies assigned and communicate same to end users.

Requirements:

  • Bachelor’s degree in a relevant discipline
  • 4+ years of experience in the pharmaceutical industry-Clinical Operations and TMF related technical skills
  • Independently motivated, detail oriented and good problem solving ability.
  • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
  • Excellent communication skills and ability to influence across multiple functions.

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.