Remote eTMF specialist

Enterprise Search Associates

Waltham Massachusetts

United States

Customer Service / Call Center
(No Timezone Provided)

Manager or Assistant Director of Records Management (eTMF) provides expertise, oversight, implementation of systems and process improvement and training related to the trial master file (TMF) and eTMF systems, and other clinical trial documentation. The incumbent will ensure GCP compliance and inspection readiness related to clinical records management within the clinical operations department. This individual will report to the Associate Director of Records Management.

Essential Responsibilities:

  • Acts as the clinical operations TMF/eTMF process owner by providing expertise, best practices related to the clinical records management, system implementation and training development.
  • Provide strategic input, management and oversight of the TMF/eTMF, including implementation of systems, oversight plans, process documents, tools and templates related to TMF/eTMF.
  • Perform routine sponsor oversight reviews of study TMF/eTMF to ensure study is inspection ready.
  • Oversee the CRO/Vendors compliance to quality records management (TMF/eTMF) to ensure goals and deliverables are met with quality as per contracted scope of work and in compliance with ICH/GCP and regulatory guidelines.
  • A contributing member of cross-functional study teams ensuring GCP compliance and implementation of the TMF oversight plan quality goals and make sure timelines are met, in compliance of SOPS and regulatory guidelines, while fostering a collaborative team culture.
  • Identify and/or anticipate GCP and quality risks and plan accordingly for mitigation and escalate issues to management as necessary.
  • Assist with site/sponsor audits and regulatory inspections, assisting with in-house and site inspection readiness planning and training.
  • Experience and Qualifications:

  • 5 years’ experience in a pharmaceutical, biotechnology or clinical research organization (CRO) setting.
  • 3+ years’ experience with trial master file/records management, oversight, maintenance, document review and QC is required.
  • TMF audit and/or regulatory inspection preparation/readiness (site and/or sponsor) and/or related quality/compliance position is preferred.
  • Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
  • Excellent communication skills, ability to build strong relationships with peers, cross functional team members and the CRO partners.
  • Excellent computer software skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).
  • Requires a BS or equivalent in the health or life sciences is preferred.
  • Work Environment:

    This is a remote position. Therefore, the individual will be working from their home office. There may be an occasional need to go into the Boston office for company meetings.

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

    Remote eTMF specialist

    Enterprise Search Associates

    Waltham Massachusetts

    United States

    Customer Service / Call Center

    (No Timezone Provided)

    Manager or Assistant Director of Records Management (eTMF) provides expertise, oversight, implementation of systems and process improvement and training related to the trial master file (TMF) and eTMF systems, and other clinical trial documentation. The incumbent will ensure GCP compliance and inspection readiness related to clinical records management within the clinical operations department. This individual will report to the Associate Director of Records Management.

    Essential Responsibilities:

  • Acts as the clinical operations TMF/eTMF process owner by providing expertise, best practices related to the clinical records management, system implementation and training development.
  • Provide strategic input, management and oversight of the TMF/eTMF, including implementation of systems, oversight plans, process documents, tools and templates related to TMF/eTMF.
  • Perform routine sponsor oversight reviews of study TMF/eTMF to ensure study is inspection ready.
  • Oversee the CRO/Vendors compliance to quality records management (TMF/eTMF) to ensure goals and deliverables are met with quality as per contracted scope of work and in compliance with ICH/GCP and regulatory guidelines.
  • A contributing member of cross-functional study teams ensuring GCP compliance and implementation of the TMF oversight plan quality goals and make sure timelines are met, in compliance of SOPS and regulatory guidelines, while fostering a collaborative team culture.
  • Identify and/or anticipate GCP and quality risks and plan accordingly for mitigation and escalate issues to management as necessary.
  • Assist with site/sponsor audits and regulatory inspections, assisting with in-house and site inspection readiness planning and training.
  • Experience and Qualifications:

  • 5 years’ experience in a pharmaceutical, biotechnology or clinical research organization (CRO) setting.
  • 3+ years’ experience with trial master file/records management, oversight, maintenance, document review and QC is required.
  • TMF audit and/or regulatory inspection preparation/readiness (site and/or sponsor) and/or related quality/compliance position is preferred.
  • Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
  • Excellent communication skills, ability to build strong relationships with peers, cross functional team members and the CRO partners.
  • Excellent computer software skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).
  • Requires a BS or equivalent in the health or life sciences is preferred.
  • Work Environment:

    This is a remote position. Therefore, the individual will be working from their home office. There may be an occasional need to go into the Boston office for company meetings.

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.