Clinical Trial Disclosure Manager

2 maanden geleden

Utrecht, Utrecht, Nederland Genmab Voltijd

Position Overview

At Genmab, we are dedicated to ensuring transparency in clinical research. We understand the scientific and ethical importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and stakeholders alike. The Clinical Trial Disclosure & Transparency (CTD&T) team operates within Development Operations, which encompasses vital functions for the effective management and reporting of clinical trials.

We are expanding our CTD&T team and are seeking a Manager to take on engaging and developmental responsibilities. This role offers a unique opportunity to collaborate with a team of passionate and innovative professionals.

Key Responsibilities

  • Oversee, manage, and ensure the public disclosure of clinical trial protocols, results, and document redactions.
  • Create and maintain timelines for protocol registration and results disclosure activities on relevant trial registries/platforms, collaborating closely with disclosure vendors as necessary.
  • Author and supervise the creation of plain language summaries of trial results.
  • Develop and revise standard operating procedures (SOPs), templates, and manage the implementation of necessary systems and technology, including AI solutions.
  • Provide training to internal staff and vendors on disclosure processes to guarantee regulatory compliance.
  • Monitor the external environment to ensure adherence to industry guidelines.
  • Manage unsolicited inquiries via the designated mailbox.
  • Represent Development Operations in various inter-departmental initiatives.

Qualifications

  • A minimum of a bachelor’s degree.
  • At least 5 years of experience in the pharmaceutical industry with a solid understanding of clinical development.
  • Exceptional written and verbal communication skills.
  • Previous experience in clinical trial disclosure is highly preferred.

Personal Attributes

  • A proactive team member with a positive and collaborative attitude.
  • Goal-oriented and improvement-focused with a proven history of meeting deadlines.
  • Strong organizational abilities with the capacity to prioritize tasks effectively.
  • A demonstrated commitment to integrity, accuracy, and attention to detail.
  • Dedicated to contributing to the overall success of Genmab.

Work Environment

Genmab promotes an agile working environment that enhances employee work-life balance. Our offices are designed as open, community-oriented spaces that foster collaboration while being integrated with our advanced laboratories. Whether working in our thoughtfully designed office spaces or remotely, we emphasize the importance of connection and innovation.

  • Clinical Trial Disclosure Manager

    1 maand geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    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...

  • Clinical Trial Disclosure Manager

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Position OverviewAt Genmab, we prioritize the transparency of clinical research. We understand the importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and stakeholders alike. The Clinical Trial Disclosure & Transparency (CTD&T) team is an integral part of our Development Operations, which encompasses essential...

  • Manager Clinical Trial Disclosure

    2 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Job SummaryThe Clinical Trial Disclosure & Transparency team at Genmab is seeking an experienced Manager to oversee the public disclosure of clinical trial protocols, results, and redaction of documents. This role requires excellent communication skills, attention to detail, and the ability to work in a fast-paced environment.Manage, track, and maintain...

  • Clinical Trial Disclosure Manager

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Position OverviewAt Genmab, we are dedicated to the transparent dissemination of clinical trial information. We understand the critical importance of sharing clinical trial data in a timely and unbiased manner to enhance patient outcomes and support external stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team is an integral part of our...

  • Clinical Trial Disclosure Manager

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Position OverviewAt Genmab, we prioritize the transparency of clinical research. We understand the scientific and ethical importance of disseminating clinical trial information in an unbiased and timely manner to benefit patients and other stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team operates within Development Operations, which...

  • Clinical Trial Disclosure Manager

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Position OverviewAt Genmab, we prioritize the transparency of clinical research. We understand the importance of sharing clinical trial data in a timely and unbiased manner to benefit patients and other stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team operates within Development Operations, which encompasses essential functions for the...

  • Clinical Trial Disclosure Manager

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Position OverviewAt Genmab, we prioritize the openness of clinical research. We understand the scientific and ethical importance of disseminating clinical trial data in a timely and unbiased manner to benefit patients and other stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team is part of Development Operations, which encompasses...

  • Manager of Clinical Trial Transparency

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    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 transparent disclosure of clinical trial information across our global portfolio.Key ResponsibilitiesPublic Disclosure Management:...

  • Transparency and Disclosure Manager

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    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 global portfolio.Key ResponsibilitiesPublic Disclosure...

  • Clinical Trial Operations Specialist

    2 maanden geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Job SummaryBristol Myers Squibb is seeking a highly skilled Clinical Trial Monitor to join our team. As a Clinical Trial Monitor, you will be responsible for ensuring the smooth conduct of clinical trials at investigator sites. This includes identifying and assessing potential investigators, developing site relationships, and conducting monitoring activities...

  • Associate Director, Clinical Trial Operations Manager

    4 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly skilled and experienced Associate Director to join our Clinical Trial Team at Genmab. As a key member of our team, you will be responsible for managing a team of Clinical Trial Associates and providing strategic leadership to drive the success of our clinical trials.Key ResponsibilitiesTeam Management: Lead and manage a...

  • Associate Director, Clinical Trial Associate Manager

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly skilled and experienced Associate Director to join our Clinical Trial Associate Team as a Clinical Trial Associate Team Manager (CTA TM). This is a key leadership role within our Trial Strategy and Delivery department, responsible for managing a team of Clinical Trial Associates (CTAs) and supporting the delivery of...

  • Clinical Trials Coordinator

    2 maanden geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    {"h1": "Project Executive, Site Management", "p": "The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed).", "ul": ["Support project feasibility assessment", "Perform project logistics planning and coordination", "Coordinate research ethics...

  • Clinical Trials Data Specialist

    2 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Clinical Trials Data SpecialistThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine. We are seeking a highly skilled Clinical Trials Data Specialist to join our team.Main Responsibilities:Develop data management plans and design Electronic Case Report Forms (eCRFs).Set up study...

  • Clinical Trial Associate Team Lead

    2 dagen geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    Job Description:At Genmab, we're committed to developing innovative treatments that change the lives of patients and the future of cancer treatment. We're seeking a talented Clinical Trial Associate Team Manager to join our team in the Trial Strategy and Delivery department.Key Responsibilities:Team Leadership: Lead and manage a team of Clinical Trial...

  • Clinical Trials Coordinator

    4 weken geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Job Summary:The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed). We are seeking a high-calibre talent to join our Site Management Unit (SMU) as a Senior Project Executive, Site Management.Main Responsibilities:Support project feasibility...

  • Clinical Trials Data Specialist

    1 week geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Clinical Trials Data SpecialistThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine. We are seeking a highly skilled Clinical Trials Data Specialist to join our team.Main Responsibilities:Develop data management plans;Design and develop Electronic Case Report Forms (eCRF), set-up...

  • Clinical Trial Associate Team Lead

    4 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly skilled and experienced Associate Director to join our Clinical Trial Team at Genmab. As a key member of our team, you will be responsible for managing a team of Clinical Trial Associates and providing strategic leadership to drive the success of our clinical trials.Key ResponsibilitiesTeam Management: Lead and manage a...

  • Project Manager, Clinical Trials

    1 maand geleden

    Utrecht, Utrecht, Nederland HKU Voltijd

    Project Executive, Site ManagementThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed). We are seeking a high-calibre talent to join our Site Management Unit (SMU) as a Project Executive, Site Management.Main Responsibilities:Support project...

  • Clinical Trials Specialist

    2 dagen geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Working at Bristol Myers SquibbAt Bristol Myers Squibb, we're committed to transforming patients' lives through science. Our clinical trials are a crucial part of this mission, and we're seeking a skilled Clinical Trial Monitor to join our team.ResponsibilitiesIdentify and assess potential Investigators and their sites to ensure they have the resources and...