Clinical Data Operations Lead
2 days ago
We are seeking a skilled Senior Clinical Data Manager to lead our clinical data operations team.
About the RoleThis is an exciting opportunity to join Genmab's dynamic and innovative company as a Senior Clinical Data Manager. As part of our global Clinical Operations team, you will play a key role in ensuring the success of our clinical trials from planning to closure.
The ideal candidate will have significant hands-on experience in clinical data management practices, with a strong understanding of GCPs, SOPs, regulatory requirements, and good data management practices. Experience within oncology trials is highly preferred.
Key Responsibilities- Act as the point of contact for DM activities for multiple trials, providing oversight of data collection and management per regulatory and industry standards.
- Provide oversight of the DM CRO and ensure performance against key indicators; provide DM expertise to trial teams.
- Lead the creation of the Data Review and Cleaning Plan and development of the data cleaning strategy.
- Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
- Review CRFs to ensure alignment with protocol; lead and perform sponsor acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
- Define and perform data quality checks and take action to ensure data quality.
- Provide oversight of key DM documentation and ensure inspection readiness; ensure documentation is aligned with best practices and provide improvement recommendations based on DM expertise.
- Drive DM oversight of data releases/DBLs and ensure timely delivery of data deliverables in accordance with Genmab SOPs and ICH/GCP; ensure data quality for analysis and reporting; prepare for regulatory filings and inspections.
- Drive and support vendor qualification for data management; define/specify scope of work for functional tasks.
- Support process improvement and knowledge management by participating in or leading task forces/projects.
- Bachelor's degree in science or related area.
- 5-8+ years of experience in clinical data management experience in biotech/pharma industry; significant hands-on end-to-end experience in clinical data management practices.
- Experience within oncology trials highly preferred.
- Experience with clinical trials and the drug development process.
- Significant experience leading data management activities for multiple clinical trials; proficient use of data management systems; advanced knowledge of DM processes, tools, methodologies, and documentation; strong understanding of DM strategy.
- Experience and understanding of GCPs, SOPs, regulatory requirements, and good data management practices.
- Experience with CDISC (SDTM) as well as data collection requirements in oncology trials preferred.
- Project management experience.
The estimated salary range for this position is $120,000-$160,000 per year, depending on location and experience. We offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
About UsGenmab is a global biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. We thrive on connecting with each other to innovate and drive progress in our field. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.
-
Clinical Data Manager Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionGenmab is seeking a skilled Clinical Data Manager to join our team.Job SummaryThe Senior Clinical Data Manager will be operationally responsible for tasks within the planning, start-up, conduct, and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.Key ResponsibilitiesRepresent Clinical Operations...
-
Clinical Data Manager Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe Senior Clinical Data Manager will be responsible for the operational management of clinical trials from planning to closure.Key Responsibilities:Manage clinical databases and ensure data qualityLead data management activities for multiple trialsDevelop and implement data validation plansEnsure data compliance with regulatory requirements...
-
Clinical Data Manager
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeClinical Data Manager - Planning and Operations LeaderThe role of a Clinical Data Manager is crucial in the planning and operation of clinical trials. As a Clinical Data Manager - Planning and Operations Leader, you will be responsible for managing clinical data from planning to closure. This includes designing and setting up clinical databases, collecting...
-
Lead Clinical Data Management Specialist
4 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title: Lead Clinical Data Management SpecialistAt Genmab, we are seeking an experienced Clinical Data Management Specialist to join our team.About the Role:We are looking for a seasoned professional with expertise in clinical data management to lead our data management activities.The successful candidate will be responsible for managing clinical trials...
-
Clinical Data Management Lead
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title: Clinical Data Management LeadGenmab is seeking a highly skilled Clinical Data Management Lead to join our team. As a key member of our Clinical Data Management team, you will play a pivotal role in overseeing the acquisition and integration of third-party data, ensuring its alignment with clinical trials' objectives and regulatory...
-
Clinical Data Management Lead
6 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Clinical Data Management Lead to join our team at Genmab. As a Senior Clinical Data Manager, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.Key ResponsibilitiesRepresent...
-
Clinical Data Management Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title: Senior Clinical Data ManagerAbout the JobGenmab is seeking a highly skilled Senior Clinical Data Manager to join our team. As a Senior Clinical Data Manager, you will play a key role in the planning, execution, and closure of clinical trials. This is an exciting opportunity to work with a talented team of professionals who are passionate about...
-
Senior Clinical Data Manager
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRole OverviewThe Senior Clinical Data Manager position at Genmab is a key role that supports the planning, start-up, conduct, and closure of clinical trials. You will be operationally responsible for tasks within the clinical trial process and will represent Clinical Operations Data Management on the Clinical Trial Team.Key ResponsibilitiesAs a Senior...
-
Clinical Data Management Lead
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob SummaryWe are seeking a highly skilled Clinical Data Management Lead to join our team at Genmab. As a key member of our Clinical Data Management team, you will play a pivotal role in overseeing the acquisition and integration of third-party data, ensuring its alignment with clinical trials' objectives and regulatory standards.Key ResponsibilitiesLead and...
-
Senior Clinical Data Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Data Manager to join our team at Genmab. As a key member of our Clinical Operations team, you will be responsible for ensuring the high-quality management of clinical trial data.Key ResponsibilitiesRepresent Clinical Operations Data Management on the Clinical Trial Team and collaborate with...
-
Clinical Data Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAs a Clinical Data Manager within our Clinical Data Management team, you will play a pivotal role in overseeing the acquisition and integration of third-party data to ensure its alignment with clinical trials' objectives and regulatory standards.ResponsibilitiesLead and Provide Strategic InsightsStandardize data type specifications to align with...
-
Senior Clinical Data Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAs a Senior Clinical Data Manager at Genmab, you will be operationally responsible for tasks within the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.You will represent Clinical Operations Data Management on the CTT, and with partners and/or Data Management/Statistical...
-
Senior Clinical Data Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe Senior Clinical Data Manager will play a key role in the planning, start-up, conduct and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.Key ResponsibilitiesRepresent Clinical Operations Data Management on the CTT, and with partners and/or Data Management/Statistical vendors.Support the overall...
-
Senior Clinical Data Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThe Senior Clinical Data Manager will be responsible for the operational management of clinical trials from planning to closure. This includes representing Clinical Operations Data Management on the Clinical Trial Team and collaborating with partners and vendors.Key ResponsibilitiesLead the creation of the Data Review and Cleaning Plan and...
-
Senior Clinical Data Manager
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAs a Senior Clinical Data Manager at Genmab, you will be operationally responsible for tasks within the planning, start-up, conduct, and closure of clinical trials from final synopsis and/or a Clinical Trial Team (CTT) is assigned.You will represent Clinical Operations Data Management on the CTT, and with partners and/or Data Management/Statistical...
-
Senior Clinical Data Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a highly skilled Senior Clinical Data Manager to join our team. As a key member of our Clinical Operations Data Management team, you will be responsible for ensuring the quality and integrity of clinical trial data.Key ResponsibilitiesLead the planning, execution, and closure of clinical trials, ensuring compliance with...
-
Principal Clinical Data Management Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleClinical Data Management Specialist Position OverviewGenmab is seeking an experienced Senior Clinical Data Manager to join our team. As a Senior Clinical Data Manager, you will be responsible for the operational management of clinical trials, including data management, database design, data collection, data validation, and data cleaning. You will...
-
Senior Clinical Data Manager
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Senior Clinical Data Manager to join our team at Genmab. As a key member of our Clinical Operations team, you will be responsible for ensuring the high-quality management of clinical data across multiple trials.Key ResponsibilitiesLead the development of clinical database designs and ensure data collection and...
-
Cardiovascular Clinical Research Lead
2 weeks ago
Copenhagen, Copenhagen, Denmark IQVIA Full timeAbout the Role:IQVIA is seeking a highly experienced Medical Strategy Lead to join our Cardiovascular team. As a subject matter expert in Cardiology, this role will drive growth of our Cardiovascular portfolio through scientific and clinical expertise.Responsibilities:Develop innovative, evidence-based delivery strategies and solutions for Cardiovascular...
-
Clinical Data Management Director
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionThe role of Clinical Data Management Director 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 strategic input to support Genmab clinical...
