Clinical Document Management Specialist

7 days ago


London, Greater London, United Kingdom Novartis Full time

At Novartis, we're committed to delivering exceptional results and fostering a culture of innovation. As a Clinical Document Management Specialist, you'll play a critical role in shaping our clinical document management systems, processes, and standards.

Job Summary:

We're seeking an experienced professional with expertise in clinical documentation practices and processes to join our team. This is a unique opportunity to work with a global, cross-functional organization and contribute to the development and implementation of cutting-edge clinical document management strategies.

Key Responsibilities:
  • Lead the implementation of CDGM initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards
  • Drive efficient and effective management, coordination, and oversight of CSR appendices for assigned studies to meet electronic publishing requirements, Health Authority guidelines, Good Clinical Practices, and Novartis SOPs
  • Support the development and maintenance of submission readiness processes, contributing to or driving initiatives to improve and innovate business and technical aspects of submission readiness activities
  • Serve as Subject Matter Expert on CSR appendices training materials, formal and informal processes, and tracking tools for CSR appendices oversight activities
Requirements:
  • Bachelor's degree in life-sciences/healthcare/pharmacy/information management and relevant industry experience
  • Thorough knowledge of clinical document management processes and advanced knowledge of clinical documentation practice guidelines & principles (Good Documentation Practice, Data integrity, ICH eCTD, and FDA Portable Document formatting specifications guidance)
  • Experience of authoring, compilation, and formatting of CSR appendices according to ICH E3 and 5 years in clinical development/clinical operations or similar business area
  • 2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
About Us:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. We offer competitive salaries and benefits packages, including health insurance, retirement plans, and paid time off. Our employees enjoy opportunities for growth and development, access to innovative products and services, and a dynamic work environment that fosters collaboration and creativity.

Estimated salary: £60,000 - £80,000 per annum



  • London, Greater London, United Kingdom Hays Specialist Recruitment Limited Full time

    Medical Writer Opportunity in Rare DiseasesHays Specialist Recruitment Limited is seeking a skilled Medical Writer to join their team for a 6-month contract in the rare diseases arena. As a Regulatory/Clinical Medical Writer, you will be responsible for creating high-quality regulatory and clinical documents, including protocols, core dossiers, CSRs, and...


  • London, Greater London, United Kingdom MMS Holdings Inc Full time

    Job Title: Clinical Development Document SpecialistAbout MMS Holdings Inc.MMS Holdings Inc. is a global leader in contract research organization services, supporting the pharmaceutical, biotech, and medical device industries with data-focused solutions. Our mission is to deliver high-quality clinical development documents that meet rigorous regulatory...


  • London, Greater London, United Kingdom Healthcare Businesswomen's Association Full time

    We are seeking a highly skilled Clinical Document Governance Specialist to join our team at the Healthcare Businesswomen's Association. This is a hybrid role that can be based in Dublin or London offices, with an expectation of being in the office 12 days/month.Job DescriptionThe successful candidate will be responsible for ensuring delivery and oversight of...


  • London, Greater London, United Kingdom Lifelancer Full time

    Job DescriptionLifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, and health sciences.We are seeking a Clinical Document Specialist to support our global clients in the biotech industry. The successful candidate will be responsible for quality control review of clinical documents intended for submission to...


  • London, Greater London, United Kingdom Lifelancer Full time

    Job Title:Senior Medical Editor - Clinical Document SpecialistAbout the Role:We are seeking an experienced Senior Medical Editor to join our team as a Clinical Document Specialist. This role will be responsible for ensuring the quality and accuracy of clinical documents intended for submission to health authorities worldwide.Key Responsibilities:Document...


  • London, Greater London, United Kingdom Richmond Pharmacology Full time

    Job OverviewRichmond Pharmacology is a leading Contract Research Organisation specialising in early-phase clinical trials. We are seeking a highly skilled Medical Writer to join our team in London Bridge.We offer a competitive salary of £45,000 - £60,000 per annum, plus benefits including private medical and dental insurance, pension scheme, and 25 days...


  • London, Greater London, United Kingdom Lifelancer Full time

    Job DescriptionThis role involves providing quality control review of clinical documents intended for submission to health authorities worldwide. The Senior Medical Editor will copyedit/proofread, format, and verify data content in clinical documents in accordance with SOPs and processes to ensure documents meet required standards.Responsibilities:Perform QC...


  • London, Greater London, United Kingdom George Buckland Life Sciences Recruitment Full time

    We are seeking a highly skilled Clinical Documentation Expert to join our team at George Buckland Life Sciences Recruitment. As a Clinical Documentation Expert, you will be responsible for creating accurate and comprehensive clinical documentation, focusing on the therapeutic areas of Oncology and Endocrinology.In this role, you will work closely with a...


  • London, Greater London, United Kingdom Wellington Management Company, LLP Full time

    About the RoleWe seek an experienced professional to join our Investment Product and Fund Strategies (IPFS) group as a Regulatory Documentation Specialist. In this role, you will be responsible for creating, overseeing, and maintaining regulatory documentation for the WMF Global business.Responsibilities:Prospectus Cycles: Manage the end-to-end process for...


  • London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Job Summary:Clinical Professionals Limited seeks a skilled Clinical Specialist to drive product advocacy and pathways across the territory.Key Responsibilities:Liaise with NHS stakeholders, HCPs, KOLs, and advocates to promote product adoption.Collaborate with established brands in Consumer and Clinical settings.Travel to the North of England and occasional...


  • London, Greater London, United Kingdom George Clinical Full time

    About George ClinicalGeorge Clinical is a leading global clinical research organization that has been driving scientific excellence and operational efficiency for over 20 years.With a strong presence in the Asia-Pacific region, USA, and Europe, we offer a full range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers.Our...


  • London, Greater London, United Kingdom MMS Holdings Inc Full time

    MMS Holdings Inc is a leading CRO that supports the pharmaceutical, biotech, and medical device industries with a data-focused approach to complex trial data and regulatory submission challenges.Job SummaryWe are seeking an experienced Regulatory Document Specialist to join our team. This role will involve critically evaluating, analyzing, and interpreting...


  • London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Job Title: Associate Director of Medical WritingJob Overview:Clinical Professionals Limited is seeking an experienced Associate Director of Medical Writing to lead our medical writing activities and serve as an expert Medical Writer. The successful candidate will be responsible for planning, developing, and writing clinical and regulatory documents to...


  • London, Greater London, United Kingdom Knightwood Associates Full time

    Document Management SpecialistA key role has become available for a skilled Document Management Specialist to join a respected residential developer in South West London. This exciting opportunity will see the successful candidate working on an impressive residential scheme, utilizing their expertise to ensure seamless document management.Key...


  • London, Greater London, United Kingdom Worldwide Clinical Trials Full time

    Worldwide Clinical Trials, a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality.Anchored in our company's scientific heritage, we develop flexible plans and solve problems quickly for our customers...


  • London, Greater London, United Kingdom Thames Water Full time

    Job Summary">We are seeking a skilled Document Management Specialist to join our team at Thames Water. This role provides an exciting opportunity to develop your career and contribute to the delivery of strategic regional water resources solutions.As a Document Management Specialist, you will play a crucial role in supporting our team to deliver client-side...


  • London, Greater London, United Kingdom Acciona S.A Full time

    At Acciona S.A., we are seeking a skilled Document Management Specialist to join our team. In this role, you will be responsible for managing and filing all project information within our document management system, ASITE. This includes ensuring that all project information is accurate and up-to-date, and guaranteeing that the required quality management...


  • London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Clinical Professionals Limited is seeking a Clinical Advocacy Specialist to join their team in the North of England. This role involves working with NHS stakeholders, HCPs, KOLs, and advocates across the territory to drive product advocacy, pathways, and prescription initiations.About the RoleThe primary aim of this role is to utilise your clinical knowledge...


  • London, Greater London, United Kingdom UCC Holding Full time

    About the RoleThis exciting opportunity has arisen for a highly organized and detail-oriented Document Management Specialist to join our expanding team in Central London. As a Senior Document Controller, you will play a vital role in coordinating document flow, tracking revisions, and providing support to the project team.You will be responsible for...


  • London, Greater London, United Kingdom Pulse Infoframe Full time

    Pulse Infoframe is a leading global health technology company focused on cancer and rare/orphan diseases. Our mission is to advance medical knowledge by sharing data across boundaries, making us leaders in Real World Data/Evidence. Our customers include top pharmaceutical and biotechnology companies, academic medical centers, and patient advocacy...