Job #6003 - Clinical Portfolio Specialist

Description:

Clinical Portfolio Specialist under the supervision of the Operations Manager will support the delivery of overall quality, completeness and timely processing of core regulatory documents, the overall electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) from Site Selection until Site Close; and support study start-up activities such as tracking and CTMS data entry and quality.

 

  • Support the release, follow-up and tracking of the Full Regulatory Package (FPP), Amendments, Investigator Brochures, and Informed Consents etc.; that are required to initiative the site and/or require an IRB Approval. Work with Central IRB to acquire EC approval for Final Protocol, Amendments, ICFs, and Patient Diaries/Questionnaires, etc.

  • Support Clinical Trial Management System (CTMS) data entry and regulatory document management lifecycle of Trial Master File (TMF) study documents at the country, site and patient level with strict adherence to ICH, GCP and FDA regulations as applicable

  • Support the Field Monitoring and Clinical Study Management Organization, in the administration of CTMS and TMF data, quality, distribution and reporting. Such as

    • Provide trial site setup and personnel updates in global clinical planning and tracking database (IMPACT)

    • Track screening activities, create and maintain the Master Investigator lists for all clinical trials during the entire site selection and approval process

    • Provide CTMS system support for Clinical Research Associates, Regional Associate Directors, and Clinical Study Managers to address questions/problems on host system

    • Run reports on a regular basis; governing roll-up of milestone event dates for the US

  • Assist in maintaining TMF (hard and electronic versions), Safety Notifications, Amendments and site personnel contact information within the scope of processing/scanning, quality review and compliance, archiving and tracking. Raise alerts where current status of data quality or performance is at risk to noncompliance

  • Assist in managing the quality and compliance of CTMS and TMF through use of reports/tools

  • Perform periodic regulatory document QC and reconciliation activities to ensure document quality (legibility, naming conventions etc.) standards are maintained for companies eTMF documents

  • Support tracking of activities through the use of comprehensive business reports, data extracts and other tools to maintain study, site and CTMS data quality and operations performance utilizing Excel, PowerPoint, graphing and systems skills

  • Perform extra assignments beyond assigned regular responsibilities as assigned by Manager

  • 2-3 years’ experience or equivalent competencies in clinical research including a working knowledge of clinical/regulatory development process; study start-up experience preferred

  • Knowledge of GCP/ICH guidelines and FDA regulations related to regulatory document collection

  • Good understanding of TMF document types and the ability to distinguish and segment these documents,

  • Experience with document management repository systems including workflows,  scanning and imaging

  • Proven strong Microsoft Office skills (i.e. Excel, PowerPoint)

  • Proven ability to meet timelines and manage work independently by working unilaterally or within teams

  • Detail oriented with superior organization and documentation skills

Bachelor’s degree, preferably in a life science, mathematics/statistics, computer science/information technology

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