This site uses cookies. To find out more, see our Cookies Policy

Clinical Document Specialist - Novartis. UK homebased role (R1059593) in Reading, UK at IQVIA™

Date Posted: 1/11/2019

Job Snapshot

  • Employee Type:
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Job Purpose

Support the clinical trial teams (CTT), as an extended CTT member, in the coordination of trial activities through specific tasks, including but not limited to trial master file, drug supply, preparation of selected clinical study report (CSR) appendices, and provide overall support to the clinical trial management organization as assigned.

Main Duties

Clinical Documents. Responsible for:

  • Generation, maintenance (including follow up for documents) and finalization of Trial Master File Table of Contents (TMF TOC) – Headquarters (HQ) level in document management system, for assigned trials
  • Initial Full Protocol Package (FPP) and amended FPP Checklists: Tracking and follow-up for the availability of documents generated at HQ level that are required by the countries for Health Authority and Ethics Committee submissions
  • Generation, completion and finalization of all the Clinical Study Report (CSR) Appendices that the Study Lead is responsible for, for all assigned trials
  • eTMF tracker reconciliation for CSR appendices and financial disclosure reporting – tracking, reconciling and follow up for essential TMF documents for all sites/investigators for all assigned trials
  • Ensuring correct eCTD file naming convention for identified CSR appendices for reference finalization in the document management system
  • eCTD tracker completion – populating links for (CSR Appendices which are being supported by the CRS group) essential documents
  • Interfacing with document publishers on behalf of clinical teams to ensure availability of ‘published’ quality documents that are delivered according to timelines and technical specifications
  • EOT Checklist completion – Generation, population and follow up for finalization of the checklist to confirm and allow formal close-out of the trial

Drug Supplies. Responsible for:

  • Collection and verification of the drug batch information received per patient for CSR documentation for trials without IRT tracking
  • Maintenance (including follow up) of the non-IRT drug supply tracking tool to help the clinical teams to have a clear overview of the drug inventory status at the country level, for selected studies which do not utilize an IRT system for drug supply management. This requires close collaboration with country representatives, Drug Supply Management (DSM) and Study Lead

Other duties and responsibilities, as assigned:

  • Maintenance of team portal as appropriate (e.g., correct content and links)
  • Supporting initial TMF inventory check and Gap Analysis for ongoing studies transitioned from GSK to Novartis (Oncology Clinical Development)
  • Writing/uploading CTT meeting minutes in the document management system
  • Any other document support identified for the role, as agreed/approved by Clinical Document Support Lead

Job Dimensions:

  • No direct or indirect reports
  • No financial responsibility
  • Internal impact: Supports the goal to have well-managed and effective clinical teams, through standardization and process improvements for assigned activities
  • External impact: Strong collaboration with country and monitoring organizations, as well as other line functions

Ideal Background:

  • Candidate with relevant work experience is preferable
  • Very strong written and verbal English
  • Advanced degree or equivalent qualification
  • Advanced MS Word and MS Excel are required
  • Experience working with documentation systems
  • Strong interpersonal skills, customer focused, and ability to work independently, managing multiple priorities across a highly matrixed global organization
  • Well-organized, detail-oriented and excellent follow-up skills
  • Good oral and written communication skills are required
  • Working knowledge of the various types of clinical documents is preferred
  • Basic understanding of the clinical drug development process and Good Clinical Practice is a plus

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

Job ID: R1059593