RHO

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Senior TMF Specialist

Senior TMF Specialist

ID 
2017-1362
Job Location 
US-NC-Chapel Hill
Type 
Regular Full-Time

More information about this job

Overview

The Senior TMF Specialist is integral to driving the success of each study specific Trial Master File (TMF) from study start-up through study close-out. The Senior TMF Specialist contributes to the management and success of the overall TMF business process, eTMF solution and assigned study specific TMFs with the goal to ensure high quality and compliant TMFs. This position provides leadership and guidance across study teams, functions and vendor partners. The Sr. TMF Specialist is responsible for Quality Control of both standard and complex TMF content. This position will participate as a study team member and will collaborate with functional SMEs to address consistent quality gaps. The Senior TMF Specialist will support continued progress for TMF Services and will mentor TMF Specialists.

Responsibilities

  • Lead cross-functional efforts toward standardizing processes and maintaining compliance
  • Develop and deliver training on all things eTMF
  • Triage system issues and escalate as needed as well as support system upgrades
  • Assist project team in preparation for internal/external audits
  • Use critical thinking skills to identify effective and efficient solutions for complex problems; to quickly grasp new practices and derive opportunities for improvement
  • Quickly adapt to evolving needs and priorities
  • Manage current and upcoming study assignments
  • Oversee day to day activities and status of current progress for all assigned studies through study lifecycle
  • Support efforts to keep leadership apprised of eTMF business process progress
  • Support change management initiative by contributing to communication and other engagement strategies
  • Ensure quality of eTMF in accordance with Rho SOPs. This requires daily QC activity and ongoing reviews to ensure compliance and inspection readiness at all times, including confirming that the content collectively provides an accurate reconstruction of the trial
  • Assist project team in preparation for internal/external audits
  • Attend and contribute to study team meetings as needed and complete study specific training for assigned studies
  • Maintain a thorough understanding of study management tasks and responsibilities necessary for ensuring compliance with protocol and regulatory requirements
  • Maintain a thorough understanding of the TMF Reference Model and stay informed of industry trends
  • Liaise with study team as they secure Site Essential Documents, confidentiality agreements, master service agreements, clinical trial agreements as appropriate and prioritize sites for IP Release approval
  • Contribute to the ongoing development of the eTMF as a vehicle for IP Release
  • Collaborate with Project Lead and Lead CRA to obtain/share trial specific issues across all study sites with a focus on quality and metrics
  • Communicate issues and support the overall escalation process of quality concerns according to Rho SOPs
  • Provide support in identification of training gaps and provision of training as needed to improve skillset and core competency
  • Maintain TMF expectations outlined by TMF Business Process Owner
  • Oversee Study Set Up process for new TMFs at trial, country and site level
  • Manage completeness accuracy for studies by maintaining the placeholders for the study and adding new placeholders when necessary, removing excused items, adding events, updating milestones, and managing priority settings where relevant
  • Contribute to overall completeness configuration by providing expert guidance and applying current trends and needs identified through study team support
  • Monitor and identify study TMF trends, completeness, and adherence to milestones and escalate as needed
  • Assist the TMF Process Owner in closing out the eTMF when the study is complete

Qualifications

  • BA/BS required, advanced degree with scientific or health care training preferred
  • A minimum of 5 years’ experience working in a clinical research/clinical development industry to include experience in managing projects
  • Relates well to all levels of staff, approachable and builds constructive and collaborative relationships
  • TMF experience required, including supporting process development and primary responsibility for TMF set-up, study start-up, maintenance and close-out
  • Familiarity with "second review" and authorization for site approval/IP activation; direct experience is preferred
  • Familiarity with TMF Reference Model
  • Demonstrable knowledge of TMF business process and clinical trial activities required for comprehension and support of company adoption
  • Ability to maintain high level of accuracy and attention to detail
  • Must exhibit professionalism, communicate effectively, and be a team player
  • Excellent oral and written communication, problem solving and organizational skills
  • Must have excellent computer skills, including experience in Word, Excel and PowerPoint, with ability to quickly and efficiently learn new eTMF and other computer systems
  • Ability to make a decision in a timely manner
  • Advanced knowledge of FDA & ICH/GCP regulations and guidelines
  • Independently motivated with good problem solving ability
  • Demonstrated ability to train, lead and mentor TMF team members
  • Ability to quickly adapt to evolving needs and priorities

EOE. Veterans/Disabled