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Sr. Study File Specialist

King of Prussia, Pennsylvania

Post Date: 06/13/2017 Job ID: 1380 Job Category: Clinical: Clinical Operations and Development

Our growing Global Pharmaceutical Client is looking for a motivated and experienced Sr. Study File Specialist. The Study File Specialist will report to a Study File Manager and work alongside other Study File Specialists as the go-to person regarding the support and process of eTMF/TMF for multiple studies. One large Phase 3 study will be starting soon and this person will have a lot of interaction with that study.  

The Study File Specialist will provide support for Trial Master File (TMF) activities to the clinical teams for 5-8 studies.  This role will be responsible for working with study teams, both internal and external, to author TMF Plans, perform document review in eTMF, assist with training and implementation of the eTMF and complete TMF completeness checks for assigned trials.  General activities include, but are not limited to:  review of TMF processes and system for continuous improvement, continued relationship building with key stakeholders and customers, and assist study teams with inspection readiness activities.  The Study File Specialist will evaluate and report on key deliverables in support and as directed by management.

The target background for this role is someone that has worked in study start up and has handled the TMF process. Someone that now only knows the documents but also knows how to set standards and how to check for accuracy and has helped teams put together a TMF plan and follow it through. Teams are global and someone that is interested in being the point person and is confident both on the phone and in person will ensure success of the position. Specialists will be working on studies that are starting and may also have some older studies that they would be reviewing.

Job Responsibilities:
  • Assist with implementing processes for Trial Master File (TMF) activities.  Liaise with study teams to facilitate knowledge and use of TMF tools and processes to standardize procedures. 
  • Assist with  implementation of the framework for a standard, global structure and maintenance of the Trial Master File (TMF)
    • Use recent audit findings and consultant review to understand current status across sites, inconsistencies and gaps
    • Continuous evaluation of electronic document repositories in use
    • Use experience and knowledge of ICH GCP and Code of Federal Regulation Guidelines to design globalized standard structure for TMF
    • Identify and develop templates, tools and processes for TMF set-up and maintenance
    • Act as vendor liaison for standardized document filing across projects
    • Collaborate with CQA and Clinical Quality Compliance team to ensure global submission and inspection readiness of TMFs as appropriate
  • Perform TMF completeness reviews within the indicated timelines to ensure TMFs are inspection ready at all times.  This includes providing guidance into the ongoing TMF QC checks study teams perform. 
  • Assist with reporting TMF related metrics to management; used to show inspection readiness and completeness of TMF. 
  • Develop and maintain strong working relationships with both internal and external collaborators and stakeholders across all geographical regions. Foster communication with management throughout the organization to promote increased cooperation and accountability. 
  • Work closely with study teams fielding, escalating and resolving TMF related issues.
  • Ad hoc support for any activities within Study Operations in support of meeting objectives or timelines.  This may include archiving study files or filing documents into the TMF

  • 4+ years clinical research experience within the pharmaceutical industry
  • Bachelor Degree in a Business related discipline.
  • Moderate experience in the set-up and maintenance of Trial Master File infrastructures and sound knowledge of regulatory requirements for global submissions
  • Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
  • Involvement in cross-functional, multicultural and international teams.
  • Excellent ability to handle complex decisions.
  • Experience in oversight of vendors highly desirable.

Nice To Have’ s:
  • Expereince using Veeva Vault
  • Experience working with standard, TMF Reference Model

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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