Clinical Data Management Specialist
3 days ago
We are seeking a seasoned Clinical Data Management Specialist to join our team in External Data Acquisition, Clinical Data Management.
This pivotal role involves overseeing the acquisition and integration of third-party data from laboratories, eCOA providers, and technology vendors who perform testing or data collection services on behalf of Genmab.
The primary responsibility is to ensure seamless data transfer processes that align with clinical trials' objectives and regulatory standards.
Key Responsibilities:- Protocol Development: Lead strategic insights into protocol development, focusing on external data collection and integration.
- Data Standardization: Standardize data type specifications to align with EDC requirements and clinical trial objectives.
- Data Transfer Compliance: Ensure data transfer processes comply with CDASH and SDTM standards for efficient data analysis and reporting.
- Data Transfer Specifications: Develop detailed data transfer specifications for acquiring external data from third-party vendors.
- Vendor Coordination: Coordinate with vendors to guarantee compatible data collection with clinical databases and meets SDTM requirements.
- CRO Oversight: Oversee Data Management Contract Research Organizations (DM CROs) for seamless external data transfers.
- Contract Review: Review and assess vendor contracts, setup specifications, and test data transfers.
- Troubleshooting: Proactively identify and resolve issues related to external data transfers throughout the trial lifecycle.
- Education: Bachelor's degree in science or a related field.
- Experience: 3-5+ years of experience in clinical data management with a focus on external data in the biotech/pharma industry.
- Knowledge: Profound knowledge of oncology trials, EDC systems, and technical aspects of data transfer.
- Data Management: Strong understanding of data management processes, tools, methodologies, and documentation.
- Regulatory Requirements: Familiarity with GCPs, SOPs, regulatory requirements, and good data management practices.
- CDISC Standards: Proficiency in CDISC (SDTM) standards and clinical data standards development.
- Project Management: Proven project management skills.
- Competitive Salary: $95,000 - $130,000 per year.
- Bonus Eligibility: Certain positions are eligible for additional forms of compensation, such as bonuses.
- Hybrid Work Arrangement: This role can be hybrid (3 days in the office/2 remote), with locations in Copenhagen, DK, Utrecht, the Netherlands, or remotely in the US (Eastern Time Zone).
- Dynamic Environment: Genmab thrives on connecting with each other to innovate in an agile working environment.
-
Lead Clinical Data Management Specialist
7 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...
-
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 Acquisition Specialist
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob Title:Senior Clinical Data Acquisition SpecialistJob Summary:We are seeking a highly skilled Senior Clinical Data Acquisition Specialist to join our Clinical Data Management team at Genmab. As a key member of our team, you will play a pivotal role in overseeing the acquisition and integration of third-party data to support our clinical trials. If you...
-
Clinical Data Manager
3 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...
-
Clinical Data Manager Lead
3 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 Acquisition Manager
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe Role:As a Senior Manager in Clinical Data Management, you will be responsible for overseeing the acquisition and integration of third-party data for clinical trials. This involves ensuring that external data collection aligns with clinical trial objectives and regulatory standards.Key Responsibilities:Develop strategic insights into protocol development...
-
Clinical Data Management Expert
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabWe are a biotechnology company dedicated to transforming the lives of patients through innovative cancer treatment. Our mission is to push the boundaries of what's possible in oncology.Senior Clinical Data Manager Role OverviewThis role offers a unique opportunity for a seasoned clinical data management expert to join our team and contribute to...
-
Clinical Data Acquisition Manager
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob SummaryWe are seeking a highly skilled Clinical Data Acquisition Manager to join our Clinical Data Management team at Genmab. As a key member of our team, you will play a pivotal role in overseeing the acquisition and integration of third-party data to support clinical trials. Your primary responsibility will be to ensure that external data collection...
-
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 trial data.Key ResponsibilitiesRepresent Clinical Operations Data Management on the Clinical Trial Team and collaborate with...
-
Clinical Data Acquisition Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob SummaryWe are seeking a highly skilled Clinical Data Acquisition Manager to join our Clinical Data Management team at Genmab. As a key member of our 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...
-
Senior Clinical Data Manager
1 month 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...
-
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...
-
Clinical Data Management Director
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAs a (Senior) Manager in External Data Acquisition, you will play a pivotal role within our Clinical Data Management team at Genmab. Your primary responsibility will be to oversee the acquisition and integration of third-party data, ensuring its alignment with clinical trials' objectives and regulatory standards.ResponsibilitiesLead and provide...
-
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...
-
Clinical Data Management Director
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe Director of Clinical Data Management at Genmab is responsible for overseeing the External Data Quality Management function, ensuring the timely delivery of high-quality external data for clinical trials.The Director will provide strategic input to support Genmab clinical development programs, ensuring external data management excellence. They will also...
-
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
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...
-
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 Acquisition Manager
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeJob SummaryThe Senior Manager of Data Management will oversee the acquisition and integration of third-party data to ensure alignment with clinical trials' objectives and regulatory standards.Key ResponsibilitiesLead and provide strategic insights into protocol development, focusing on external data collection and integration.Standardize data type...
-
Clinical Data Management Lead
4 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...
