Manager, Clinical Trial Disclosure
7 maanden geleden
The Role
& DepartmentGenmab is committed to transparency of clinical trial research. We recognize the scientific and ethical value of sharing clinical trial information in a non-biased and timely manner to benefit patients and other external stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team resides within Development Operations, which hosts key functions for ensuring successful conduct and reporting of clinical trials.
We are now expanding our CTD&T team with a Manager position. Besides interesting and developing tasks, you will get a unique opportunity to join a collaborative team of passionate and innovative colleagues.
In the role as Manager, Clinical Trial Disclosure & Transparency, you will be executing against global and national clinical trial disclosure requirements across the entire Genmab portfolio. Key responsibilities include supporting trial teams and applicable functions to ensure high-quality output and responsible disclosure of clinical trial information. Further, your responsibility includes implementation of new transparency requirements and training of staff. You will also oversee the relationship between Genmab and our disclosure vendor(s) to ensure efficiency and compliance.
Key responsibilities include
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 ClinicalTrials.gov, EU CTIS and other applicable trial registries/platforms. Work in close collaboration with disclosure vendor(s), if applicable.
Author/oversee the development of plain language results summaries.
Develop and update SOPs, templates, and oversee applicable system implementations. Assess technology/AI needs and manage implementation of required software.
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
-
Manager Clinical Trial Disclosure
1 maand geleden
Utrecht, Utrecht, Nederland Genmab VoltijdJob 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...
-
(Senior) Manager, Clinical Trial Planning
6 maanden geleden
Utrecht, Nederland Genmab VoltijdAt Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Senior Clinical Trials Coordinator
3 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdJob OpportunityWe are seeking a highly skilled Senior Clinical Trials Coordinator to join our team at the Clinical Trials Centre (HKU-CTC) in Hong Kong.About HKU-CTCThe Clinical Trials Centre is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed). Our centre is dedicated to managing and...
-
Associate Director, Global Clinical Trial Management
4 dagen geleden
Utrecht Oost, Nederland Genmab VoltijdAt Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Clinical Trials Coordinator, Technical Officer
4 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdHKU Clinical Trials Centre: A Leading Platform for Clinical Trial ManagementThe Clinical Trials Centre (HKU-CTC) at The University of Hong Kong LKS Faculty of Medicine is a premier clinical trials management platform dedicated to facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.We are seeking a...
-
Clinical Trials Operations Specialist
3 weken geleden
Utrecht, Utrecht, Nederland Bristol Myers Squibb VoltijdAbout UsBristol Myers Squibb is a leading biopharmaceutical company transforming patients' lives through science. Our innovative approach, diverse culture, and commitment to excellence make us an ideal place to grow your career.Estimated Salary: $80,000 - $110,000 per yearJob Description:We are seeking a highly motivated Clinical Trial Monitor to join our...
-
IT Administrative Assistant
3 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdCareer OpportunityAt the Clinical Trials Centre, we are seeking a detail-oriented and highly motivated individual to join our IT team as an administrative assistant. This role offers long-term development opportunities for passionate talents who pursue career advancement and success.About UsThe Clinical Trials Centre is a leading clinical trials management...
-
Lead Clinical Data Manager
4 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdAbout the RoleThe HKU Clinical Trials Centre is seeking a highly skilled Clinical Data Coordinator to join our team. This role will be responsible for developing data management plans, designing Electronic Case Report Forms (eCRFs), and performing quality assurance/quality control on clinical data.Main Responsibilities:Develop data management plan;Design and...
-
Clinical Trials Professional
3 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdJob DescriptionThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine, dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies. HKU-CTC offers long-term development opportunities to passionate talents who...
-
Senior Laboratory Associate for Clinical Trials
4 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdThe Clinical Trials Centre (HKU-CTC) at the University of Hong Kong is a leading clinical trials management platform dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.HKU-CTC offers long-term development opportunities to passionate talents who are devoted to a career in the...
-
Clinical Data Manager
3 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdOverviewThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine, dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.HKU-CTC offers long-term development opportunities to passionate talents devoted to a...
-
Senior Project Coordinator, Clinical Trials
4 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdClinical 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 dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices and medical technologies.Main Responsibilities:Support project feasibility...
-
Clinical Trial Monitor
6 maanden geleden
Utrecht, Nederland Bristol-Myers Squibb Voltijd**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Clinical Trials Coordinator
4 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdHKU-CTC Clinical Trials CentreThe HKU-CTC Clinical Trials Centre is a leading clinical trials management platform established under The University of Hong Kong LKS Faculty of Medicine (HKUMed). Our centre is dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices and medical technologies.We are seeking a...
-
Associate Director, Global Clinical Trial Management
1 maand geleden
Utrecht, Nederland Genmab VoltijdAt Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Senior Clinical Trial Associate
6 maanden geleden
Utrecht, Nederland Genmab VoltijdThe Role & DepartmentThe Senior Clinical Trial Associate (CTA) is responsible for overseeing filing of documents (eTMF) to ensure inspection readiness at trial level & supporting GCTM/CTM with key (administrative) activities.Key responsibilitieseTMF Management:Setup, maintain and close Sponsor eTMF (trial, country, sites, EDL, upload of document).Oversight...
-
Clinical Trial Monitor
6 maanden geleden
Utrecht, Nederland Bristol-Myers Squibb Voltijd**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Senior Laboratory Professional for Clinical Trials Management
3 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdHKU-CTC, a leading clinical trials management platform in the LKS Faculty of Medicine, seeks an experienced Senior Laboratory Professional to join our team.About HKU-CTCWe are dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies. Our long-term development opportunities offer...
-
Clinical Trial Operations Specialist
4 weken geleden
Utrecht, Utrecht, Nederland Bristol Myers Squibb VoltijdUnlock a Challenging and Meaningful Career with Bristol Myers SquibbBristol Myers Squibb is an innovative biopharmaceutical company that transforms patients' lives through science. We are dedicated to delivering life-changing therapies and striving for excellence in everything we do.Compensation Package:The estimated annual salary for this position is...
-
Data Scientist for Clinical Trials
4 weken geleden
Utrecht, Utrecht, Nederland HKU VoltijdThe Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine, dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.As a Data Analyst in our team, you will be working closely with data management specialists...
