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TMF Quality Control Specialist

Date: Feb 5, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

The Trial Master File (TMF) Quality Control Specialist is responsible for performing TMF document quality control (QC) review and monitoring completeness and quality of the TMF content for all assigned clinical trials through study close out.

 

S/he will be accountable for the quality of the TMF ensuring document quality control and document remediation is performed and meets quality criteria defined in Good Documentation Practices (GDP).

 

S/he will support the TMF Leader to ensure that the TMF is audit and inspection ready for clinical trials in accordance with ICH GCP guidelines, European Medicines Agency (EMA) guidance, FDA 21 CFR Part 11 and Spark SOPs.

 

S/he will assist with the implementation of TMF specifications and lead the development of study specific TMF plans and TMF study specific document lists and ensure these are current throughout the study and finalized at study completion.

 

S/he will actively identify continuous improvement opportunities through process and metrics analysis and share lessons learned across study teams.

 

Responsibilities: 

 

90%  

  • Responsible for processing TMF documentation and performing quality control (QC) review in accordance with standard operating procedures (SOPs), work instructions (WIs), ICH GCP guidelines, TMF reference model and study specific TMF Plans.
    • Ensure TMF documents meet good documentation requirements (GDP) by confirming ALCOA-C (Attributable, Legible, Contemporaneous, Original, Accurate and Complete) principles
    • Ensure documents that fail TMF QC review are effectively remediated by internal/external document owners
    • Monitor staff progress in resolution of identified TMF discrepancies, escalate to TMF Leader as needed
  • Perform periodic study-level TMF quality, completeness and timeliness reviews at defined timepoints to ensure adherence to regulatory, ICH GCP, and industry best practices
    • Identify missing documents and notify the appropriate document owner for reconciliation in a timely manner
      • Resolve TMF queries related to audits and/or completeness reviews
      • Monitor and identify study specific TMF trends and escalate concerns to TMF Leader
  • Support study-level Veeva eTMF implementation
    • Monitor and evaluate study requirements to ensure eTMF structure is deployed in conjunction with clinical trial launch
    • Contribute to the development and assist with the implementation of eTMF specifications, such as process and system changes
    • Create and manage study specific TMF Plans and Essential Document Lists (EDLs) in collaboration with CROs and vendors
  • Serve as the TMF point of contact for internal and external (CRO) team members
    • Maintain and report TMF compliance metrics for assigned studies
    • Provide education, feedback and support to study teams in order to build knowledge and awareness of GDP
  • Oversee management of vendors providing TMF services
    • Establish and maintain collaborative relationships with TMF vendors
    • Oversee vendor TMF QC processes
  •  Assist with TMF process development
    • Perform user acceptance testing for Veeva eTMF
    • Support the set-up, maintenance, and closure of TMF repositories
    • Contribute to the development of TMF SOPs, work instructions, reference guides, naming conventions and TMF user training
  • Assist in the archiving of TMF documents; this may include shipping, retrieval, and tracking of documents approved for archiving to off-site storage; maintain electronic logs which contain the location of study documents.
  • Assist in coordination of long-term storage archival of original documents and maintain document integrity, per document retention policies

 

10%  Other duties or projects as assigned

 

Requirements: 

 

Education: Bachelor’s degree required; scientific discipline preferred

 

Experience:

Required:

  • Minimum of 3 years of related pharmaceutical/CRO TMF management experience
  • Prior experience performing TMF QC function in an electronic TMF
  • Prior experience monitoring an electronic TMF for quality, completeness and timeliness

 

Preferred:

  • Prior experience performing QC review in Veeva eTMF
  • Prior experience supporting audits and regulatory inspections

 

 

Competencies:

 

  • Knowledge of ICH/GCP documentation requirements and TMF governing regulations, such as the TMF Reference Model and ALCOA+ standard
  • Strong document management skills, including experience with review of regulatory documents
  • Ability to approach assigned duties in a highly organized, detailed and accurate manner
  • Organized and efficient, excellent attention to detail
  • Ability to work cross-functionally with other departments and external vendors involved in the conduct of a clinical study
  • Microsoft Office, PowerPoint and Excel proficiency
  • Ability to manage multiple and changing priorities and scenarios and work in a flexible, dynamic, and fast-paced environment

 

 

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Nearest Major Market: Philadelphia