Clinical Trial Disclosure Specialist
2 days ago
Genmab is an international biotechnology company driven by its core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. Our team strives towards transforming cancer treatment and serious diseases, fostering a collaborative environment where employees can thrive.
As a Sr. Associate/Manager in our Clinical Trial Disclosure & Transparency team, you will play a crucial role in executing global and national clinical trial disclosure requirements across Genmab's entire portfolio. Your responsibilities will include managing public disclosure of clinical trial protocols, results, and document redaction, developing timelines for protocol registration and results disclosure, and training internal staff and vendors on disclosure processes. Additionally, you will oversee plain language results summaries, develop SOPs, templates, and system implementations, and monitor external landscapes to ensure Genmab's adherence to relevant industry guidelines.
Your 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.
Your Qualifications
- Previous experience with clinical trial disclosure is required.
- A Bachelor's degree is minimum requirement.
- 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development is necessary.
- Excellent written and verbal communication skills are essential.
As a successful candidate, you are expected to be an engaged colleague with a positive and collaborative mindset, goal- and improvement-oriented with a proven track record of deliveries against set timelines, strong organizational skills with the ability to plan and prioritize tasks, and a proven ability to work with a high level of integrity, accuracy, and attention to details.
-
Senior Clinical Trial Disclosure Specialist
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeAt Genmab A/S, we are committed to transforming the lives of patients through innovative cancer treatment. We are seeking a highly skilled Sr. Associate/Manager, Clinical Trial Disclosure & Transparency, to join our team.Key Responsibilities:Manage and oversee public disclosure of clinical trial protocols, results, and document redaction.Develop and maintain...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeWe are seeking a highly motivated and organized Sr. Associate/Manager, Clinical Trial Disclosure & Transparency, to join our team at Genmab A/S. In this role, you will be responsible for managing and overseeing public disclosure of clinical trial protocols, results, and document redaction.Key Skills and Qualifications:Strong understanding of clinical...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering 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 science, we believe that being...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeSr. Associate/Manager, Clinical Trial Disclosure & Transparency Sr. Associate/Manager, Clinical Trial Disclosure & Transparency Location : This role can be based in Copenhagen, Denmark (DK), or Utrecht, Netherlands (NL), and offers a hybrid work arrangement. Role Overview As a Sr. Associate/Manager in the Clinical Trial Disclosure & Transparency team, you...
-
Copenhagen, Copenhagen, Denmark LEO Pharma Full timeSelect how often (in days) to receive an alert: Medical Writing and Clinical Disclosure Professional Field of work: Clinical Development Posting Date: 12 Mar 2025 Role Description Are you a skilled professional with a passion for medical writing and clinical disclosure? LEO Pharma is seeking a talented Medical Writing and Clinical Disclosure Professional to...
-
Medical Writing Expert for Clinical Disclosure
2 hours ago
Copenhagen, Copenhagen, Denmark LEO Pharma Full timeYour Role: As a Medical Writing and Clinical Disclosure Professional, you will play a crucial part in planning, managing, and writing clear, concise, and audience-friendly regulatory, scientific, and medical documents. Your main tasks will include:Writing and editing original regulatory, scientific, and medical documents at a professional level.Leading and...
-
Global Clinical Transparency Lead
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeOur PurposeWe are committed to promoting transparency in clinical trial research at Genmab. We recognize the scientific and ethical value of sharing clinical trial information in an unbiased and timely manner, benefiting patients and external stakeholders alike. Our Clinical Trial Disclosure & Transparency team plays a crucial role in ensuring successful...
-
Global Clinical Trials Logistics Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab is seeking a highly motivated and experienced Global Clinical Trials Logistics Specialist to join our team. As a Global Clinical Trials Logistics Specialist, you will be responsible for managing the logistics of clinical trial supplies, including packaging, labeling, and distribution.The Role & DepartmentYou will work closely with our CMOs and...
-
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeJob DescriptionThis is an exciting opportunity to join our dynamic CMC API QA department at Novo Nordisk A/S as a Senior Quality Assurance Specialist for Clinical Trials. As a key member of our team, you will play a critical role in ensuring the quality and safety of products for clinical trials.Your key responsibilities will include:Providing expert advice...
-
Clinical Trial Manager, Clinical Operations
2 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeClinical Trial Manager, Clinical Operations Requisition ID: 5984 Location: Copenhagen, Danish Capital Region, DK Clinical Trial Manager, Clinical Operations Do you want to join a motivated, focused global development team, work within our strong portfolio, and make a difference to patients living with brain disease? Are you motivated by having the...
-
Global Clinical Trial Lead
5 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeTransforming Lives through Innovative Clinical TrialsLundbeck A/S, H is a renowned pharmaceutical company dedicated to addressing the big unmet needs of people living with brain disorders. We are seeking a highly skilled Global Clinical Trial Lead to join our team.As a key member of our global Clinical Operations team, you will lead a cross-functional trial...
-
Global Transparency Manager
2 days ago
Copenhagen, Copenhagen, Denmark Genmab AS Full timeGenmab A/S is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics. As a Sr. Associate/Manager, Clinical Trial Disclosure & Transparency, you will play a critical role in executing global and national clinical trial disclosure requirements.About the Role:Develop and...
-
Global Clinical Trial Lead
2 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeLundbeck A/S, H is a leading pharmaceutical company dedicated to transforming lives by addressing the big unmet needs of people living with brain disorders. As a Global Clinical Trial Lead, you will play a critical role in shaping our clinical trial strategy and executing it with precision.Job DescriptionYou will be responsible for leading a global...
-
Clinical Trials Platform Engineer
2 hours ago
Copenhagen, Copenhagen, Denmark Themison Full timeAbout the ProjectWe are working on an AI-powered platform to transform clinical trials with intelligent agents. Our goal is to create a scalable, user-friendly platform that leverages cutting-edge AI technologies.The platform will enable trial managers to access relevant information quickly and efficiently. It will also provide advanced features like task...
-
Global Clinical Trials Supply Chain Manager
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe're looking for a skilled Senior Clinical Drug Supply Manager to join our team at Genmab. In this role, you will play a critical part in delivering high-quality clinical trial supplies for both early and late-stage trials.Main ResponsibilitiesYour primary responsibilities will include:Managing operational trial and project objectives.Providing direct...
-
Clinical Trials Strategy Manager
2 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeJob DescriptionLundbeck Clinical Operations is a dynamic team of over 40 global colleagues who take pride in cross-functional collaboration and share the aspiration to become world-class in trial execution. We are enthusiastic about what we do and responsible toward our deliveries, colleagues, and society.About the TeamYou will join a leadership team that...
-
Senior Trial Management Professional
2 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeSenior Trial Management Professional is a sought-after position within Lundbeck A/S, H's Global Clinical Trials department. This role requires a seasoned professional with extensive experience in managing clinical trials, specifically in brain diseases. As a Senior Trial Management Professional, you will leverage your expertise to lead cross-functional teams...
-
Clinical Trials Software Engineer
2 days ago
Copenhagen, Copenhagen, Denmark Themison Full timeAbout the RoleThis internship opportunity is ideal for students or recent graduates who are passionate about building AI-powered platforms and shaping the future of clinical trials.Responsibilities:Contribute to the design and development of the AI-powered platform.Collaborate with cross-functional teams to ensure seamless execution of project...
-
Strategic Trial Manager
2 days ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeThe Senior Clinical Operations Manager role at Novo Nordisk A/S involves leading from a strategic point of view the execution of clinical projects in assigned therapeutic areas across Region Europe & Canada (EUCAN). Key responsibilities include following up on trial status, motivating, supervising, and supporting team members, as well as coordinating...
-
Trial Management Team Lead
5 days ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeLeading Clinical Trials: A Key Role in Shaping the FutureLundbeck A/S, H is a forward-thinking pharmaceutical company focused on addressing the unmet needs of individuals affected by brain disorders. We are seeking a talented Trial Management Team Lead to join our global Clinical Operations team.In this critical role, you will lead cross-functional teams in...