Clinical Trial Disclosure Manager
6 hours ago
Genmab 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 Responsibilities- Manage, track, and maintain overall responsibility for public disclosure of clinical trial protocols, results, and redaction of documents.
- Develop and maintain timelines for authoring of protocol registration and results disclosure activities on, EU CTIS and other applicable trial registries/platforms.
- Author/oversee the development of plain language results summaries.
- Develop and update SOPs, templates, and oversee applicable system implementations.
- Train internal staff/vendors on applicable 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.
- Being a great representative for Development Operations on inter and intra-departmental initiatives.
- A minimum of a bachelor's degree.
- 5+ years of pharmaceutical industry experience with good understanding of clinical development.
- Excellent written and verbal communication skills.
- Previous experience with clinical trial disclosure is strongly preferred.
- 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 fierce believer in our rooted-in-science approach to problem-solving.
- 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.
-
Clinical Trial Associate Team Manager
6 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Trial Associate Team Manager to join our Trial Strategy and Delivery department at Genmab. As a key member of our team, you will be responsible for managing a team of Clinical Trial Associates and providing direction and support to ensure the successful execution of clinical trials.Key...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe Director, Team Lead, External Data Quality Management, Clinical Data Management at Genmab is operationally responsible for overseeing External Data Quality Management activities related to effective planning and timely delivery of complete, high-quality, and reliable external data for clinical trials.The Director will provide oversight to...
-
Copenhagen, Copenhagen, Denmark DEN Fortrea Denmark ApS Full timeFinancial Clinical Trial AssistantFortrea is seeking a detail-oriented and organized Financial Clinical Trial Assistant to join our dedicated sponsor team in Copenhagen.This role plays a crucial part in supporting our study budgets and ensuring financial accuracy for our clinical trials. The successful candidate will leverage their financial expertise to...
-
Medical Lead
1 week ago
Copenhagen, Copenhagen, Denmark Advanced Accelerator Applications (Italy) - S... Full timeAbout the RoleJob Summary:The Medical Lead will be responsible for supporting the design, implementation, and execution of Medical Affairs plans for assigned Therapy Areas. This includes providing scientific information, helping design and organize clinical studies, building informative dialogue with Key Opinion Leaders (KOLs) and regulatory customers.Key...
-
Clinical Research Associate
1 week ago
Copenhagen, Copenhagen, Denmark MSD Danmark Full timeAbout the RoleWe are seeking a highly skilled and motivated Clinical Research Associate to join our team at MSD Danmark. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials and the compliance of our research activities.Key ResponsibilitiesManage and coordinate clinical trials at various sites,...
-
Clinical Research Associate
1 week ago
Copenhagen, Copenhagen, Denmark MSD Full timeAbout the PositionWe are seeking a highly skilled Clinical Research Associate to join our team at MSD in Denmark. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials and maintaining high site performance.About the RoleAs a Clinical Research Associate, you will be responsible for:Managing clinical...
-
Clinical Research Associate
1 week ago
Copenhagen, Copenhagen, Denmark MSD Danmark ApS Full timeAbout the PositionWe are seeking a highly skilled and motivated Clinical Research Associate to join our team at MSD Danmark ApS. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials and the compliance of our research sites.Key ResponsibilitiesManage and coordinate clinical trials at research sites,...
-
Clinical Research Associate
1 week ago
Copenhagen, Copenhagen, Denmark MSD Danmark ApS Full timeAbout MSD Danmark ApSJob Title: Associate Clinical Research AssociateJob Summary:We are seeking a skilled and motivated Associate Clinical Research Associate to join our team at MSD Danmark ApS. As an Associate Clinical Research Associate, you will be an integral part of a dedicated team focused on conducting excellent clinical trials and ensuring high site...
-
Clinical Program Lead
1 week ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeAbout the RoleWe are seeking a highly skilled Clinical Program Lead to join our Global Clinical Development organization at Ferring Pharmaceuticals A/S. As a key member of our team, you will play a central role in bridging the clinical parts of our matrix organization, driving clinical development programs, and ensuring alignment of execution strategies,...
-
Customer Success Project Manager
1 week ago
Copenhagen, Copenhagen, Denmark TruLab, Real-Time Technology for Clinical Trial Oversight Full timeAbout the RoleWe are seeking a highly skilled and detail-oriented Customer Success Project Manager to join our team at TruLab, Real-Time Technology for Clinical Trial Oversight. As a key member of our team, you will be responsible for ensuring the successful execution of our projects and building strong relationships with our clients.Key...
-
Clinical Supply Chain Manager
6 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title: Senior Clinical Drug Supply ManagerGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply team in Princeton, NJ or Copenhagen, Denmark.Key Responsibilities:Develop and implement global clinical trial supply strategies to ensure timely and efficient delivery of clinical supplies.Collaborate with...
-
Clinical Research Associate
1 week ago
Copenhagen, Copenhagen, Denmark MSD Full timeAbout the PositionWe are seeking a skilled and motivated Clinical Research Associate to join our team at MSD in Denmark. As a Clinical Research Associate, you will be an integral part of a dedicated team focused on conducting excellent clinical trials and ensuring high site performance.Key Responsibilities:Manage assigned trials and sites, ensuring...
-
Associate Clinical Research Manager
2 months ago
Copenhagen, Copenhagen, Denmark MSD Full timeJob DescriptionOur Clinical Research team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.As an Associate Clinical Research Manager in Denmark, you will be primarily...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe Director, Team Lead, External Data Quality Management, Clinical Data Management at Genmab is operationally responsible for the oversight of External Data Quality Management activities related to effective planning and timely delivery of complete, high-quality, and reliable external data for clinical trials.The Director will provide...
-
Clinical Documentation Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleLundbeck is seeking a highly skilled Clinical Submission Coordinator to join our Medical Documentation team. As a key member of our team, you will be responsible for managing clinical documentation and ensuring the submission readiness of clinical trial reports and clinical submission documents across our clinical development programmes.Your...
-
Clinical Documentation Specialist
6 hours ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleLundbeck is seeking a highly skilled Clinical Submission Coordinator to join our Medical Documentation team. As a key member of our team, you will be responsible for managing clinical documentation and ensuring the submission readiness of clinical trial reports and clinical submission documents across our clinical development programmes.You...
-
Clinical Documentation Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeJob SummaryLundbeck is seeking a highly skilled Clinical Documentation Specialist to join our team. As a Clinical Documentation Specialist, you will be responsible for managing clinical documentation and ensuring the submission readiness of clinical trial reports and clinical submission documents across Lundbeck's clinical development programmes.Key...
-
Clinical Documentation Specialist
1 week ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeJob SummaryLundbeck is seeking a highly skilled Clinical Documentation Specialist to join our team. As a key member of our Medical Documentation department, you will be responsible for managing clinical documentation and ensuring the submission readiness of clinical trial reports and clinical submission documents across Lundbeck's clinical development...
-
Clinical Documentation Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Lundbeck Full timeAbout the RoleLundbeck is seeking a highly skilled Clinical Submission Coordinator to join our Medical Documentation team. As a key member of our team, you will be responsible for managing clinical documentation and ensuring the submission readiness of clinical trial reports and clinical submission documents across our clinical development programmes.Key...
-
Senior Clinical Supply Associate
6 hours ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Senior Clinical Drug Supply Associate to join our Global Clinical Drug Supply Operations team in Copenhagen or Princeton. As a key member of our team, you will play a central role in the execution of tasks related to packaging, labeling, and distribution of clinical trial supplies for early and late-stage...
