Senior Clinical Document Specialist

Job Description

100,000 and more! That s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide. But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.Your responsibilities include, but are not limited to: 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 (supports completion of CSR appendices 16.1.3 and 16.1.4), 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 appendix (16.1.6) 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 NVS (OCD); Writing/uploading CTT meeting minutes in the document management system; Any other document support identified for the role, as agreed/approved by Clinical Document Specialists Lead. Senior Clinical Document Specialist; Able to manage activities on studies with challenging set-ups (collaborative group studies, mega studies, studies with co-development partner) with limited to no additional guidance from manager. As required, assist Clinical Document Specialists Manager/Clinical Document Specialists Lead with various activities, including but not limited to: Leading process improvement sessions as required, documenting and sharing the action items as appropriate; Leading knowledge/best practice sharing, documenting and sharing the action items as appropriate; Creation of the onboarding plan for new joiners, providing identified training for them (as applicable) and act as onboarding partner; Collection of data for CDS Group metrics; Deputize and represent CDS group at various forums; Act as mentor within the CDS group.Minimum requirements Minimum of 2 years of work experience with clinical trials re quired Excellent word processing skills with advanced MS Word are required Proven experience working with computers; Experience working with documentation systems Strong interpersonal skills, customer focused, and ability to work independently managing multiple priorities across a high ly 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 Good understanding of the clinical drug development process and Good Clinical Practice is a plusWhy consider Novartis 799 million. That s how many lives our products touch. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,

Keyskills :
documentationcustomer relationsqualitygood clinical practicedocument management systemgap analysiscustomer focusclinical trialsword processingsite initiation