Clinical Trial Disclosure Specialist

3 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

Genmab is seeking a highly skilled and experienced professional to join our Clinical Trial Disclosure & Transparency team as a Sr. Associate/Manager. This role will be responsible for executing global and national clinical trial disclosure requirements across Genmab's entire portfolio.

Key Responsibilities
  • Manage, track, and oversee public disclosure of clinical trial protocols, results, and document redaction.
  • Develop and maintain timelines for protocol registration and results disclosure on platforms such as ClinicalTrials.gov and EU CTIS.
  • Author or oversee the development of plain language results summaries.
  • Develop and update SOPs, templates, and oversee applicable system implementations.
  • Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
  • Monitor the external landscape to ensure Genmab's adherence to relevant industry guidelines.
  • Management of unsolicited requests via the mailbox.
Requirements
  • Previous experience with clinical trial disclosure.
  • Bachelor's degree minimum.
  • 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development.
  • Excellent written and verbal communication skills.
About You
  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best and take pride in enabling the best work of others on the team.
  • You are not afraid to grapple with the unknown and be innovative.
  • You have experience working in a fast-growing, dynamic company (or a strong desire to).
  • You work hard and are not afraid to have a little fun while you do so.


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Clinical Trial Disclosure and Transparency SpecialistGenmab A/S is seeking a Clinical Trial Disclosure and Transparency Specialist to join our team. As a key member of our Clinical Trial Disclosure and Transparency team, you will be responsible for executing global and national clinical trial disclosure requirements across Genmab's entire portfolio.Key...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly skilled Clinical Trial Disclosure Specialist to join our Clinical Trial Disclosure & Transparency team. As a key member of our team, you will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio.Key ResponsibilitiesManage, track, and oversee public...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly skilled Clinical Trial Disclosure Specialist to join our Clinical Trial Disclosure & Transparency team. As a key member of our team, you will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio.Key ResponsibilitiesManage, track, and oversee public...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Sr. Associate/Manager, Clinical Trial Disclosure & TransparencyThis role can be based in Copenhagen, Denmark (DK), or Utrecht, Netherlands (NL), and offers a hybrid work arrangement.Key Responsibilities:Manage, track, and oversee public disclosure of clinical trial protocols, results, and document redaction.Develop and maintain timelines for protocol...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly skilled and experienced professional to join our Clinical Trial Disclosure & Transparency team as a Manager. This role will be responsible for executing against global and national clinical trial disclosure requirements across our entire portfolio.Key ResponsibilitiesManage, track, and maintain overall responsibility...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly skilled and experienced Clinical Trial Disclosure Manager to join our Development Operations team. As a key member of our team, you will be responsible for executing against global and national clinical trial disclosure requirements across our entire portfolio.Key ResponsibilitiesManage, track, and maintain overall...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly skilled and experienced Manager to join our Clinical Trial Disclosure & Transparency team. As a key member of our Development Operations team, you will play a critical role in ensuring the transparency and disclosure of clinical trial information across our entire portfolio.Key ResponsibilitiesManage and maintain...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly skilled Manager to join our Clinical Trial Disclosure & Transparency team. As a key member of our team, you will play a crucial role in ensuring the transparent disclosure of clinical trial information across our global portfolio.Key ResponsibilitiesManage and maintain the public disclosure of clinical trial...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Disclosure Manager to join our team at Genmab A/S. As a key member of our Clinical Trial Disclosure & Transparency team, you will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio.Key ResponsibilitiesManage, track, and oversee public...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the Role:Genmab is seeking a highly skilled Clinical Trial Transparency Specialist to join its Clinical Trial Disclosure & Transparency (CTD&T) team. This role will be responsible for executing global and national clinical trial disclosure requirements across Genmab's entire portfolio.Key Responsibilities:Manage, track, and oversee public disclosure of...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionThe Clinical Trials Associate Specialist role at Genmab is responsible for overseeing the filing of documents to ensure inspection readiness at the trial level and supporting Clinical Trial Governance with key administrative activities.eTMF Management:Setup, maintain, and close Sponsor eTMF (trial, country, sites, EDL, upload of...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Senior Clinical Trial Associate - Regulatory Compliance SpecialistThe RoleThe Senior Clinical Trial Associate (CTA) will oversee the filing of documents (eTMF) to ensure inspection readiness at the trial level, supporting the GCTM/CTM with key administrative activities.Key ResponsibilitiesSetup, maintain, and close Sponsor eTMF (trial, country, sites, EDL,...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is seeking a Clinical Manager for Clinical Trials to work with all aspects of clinical trial budget oversight, including budget development and vendor management support.The ideal candidate will have a solid understanding of clinical trial budgeting processes and procedures, as well as experience working with internal and external stakeholders.Key...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleThe Senior Clinical Trial Associate (CTA) at Genmab will oversee the filing of documents to ensure inspection readiness at the trial level and support GCTM/CTM with key administrative activities.ResponsibilitiesSetup, maintain, and close Sponsor eTMF (trial, country, sites, EDL, upload of documents).Oversight of eTMF (TMF-Browser, Monthly...


  • Copenhagen, Copenhagen, Denmark MeetFrank Full time

    Associate Director, Global Clinical Trial ManagerAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. We believe that being proudly unique, determined to be our best, and authentic is...


  • Copenhagen, Copenhagen, Denmark Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, we're committed to improving health outcomes through our clinical research services. As a Clinical Trial Specialist, you'll play a critical role in ensuring the success of our clinical programs.Key Responsibilities:Perform and coordinate all aspects of the clinical monitoring and site management processConduct remote or on-site...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About Clinical Trial Planning Manager RoleAt Genmab, we're dedicated to developing innovative therapies for serious diseases and cancer. We're seeking a skilled Clinical Trial Planning Manager to join our team. As a key member of our Development Program Management team, you'll play a pivotal role in managing clinical trials from initiation to final...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About Clinical Trial Planning at GenmabGenmab is a leader in the development of innovative cancer treatments, and we are seeking a highly skilled Clinical Trial Planning Manager to join our team. As a key member of our Development Program Management team, you will play a pivotal role in advancing our transformative therapies from initiation to final...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    We are looking for a highly skilled Clinical Trial Planner to join our team at Genmab. The successful candidate will play a pivotal role in managing clinical trials from initiation to final reporting, ensuring alignment with our Global Development Operations (Dev Ops) colleagues.Responsibilities:Construct and monitor clinical trial execution plans for...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're driving innovation in cancer treatment and serious diseases by developing antibody products and pioneering therapies. As a Clinical Trial Planning Manager, you'll join our Development Program Management team, part of our global Portfolio & Project Management (PPM) department.This role is pivotal in managing clinical trials from initiation to...