At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role:
The Associate Director, External Data Acquisition Lead (EDAL) role is a clinical data manager with expertise in the data collection of 3rd party data from various external providers (e.g. laboratories, eCOA providers, technology providers, etc.). The EDAL provides a leadership role in the oversight of the external clinical data integration processes as well as oversight of data quality from various external providers performing testing or data collection services on behalf of Genmab. The EDAL serves as the subject matter expert for all external data management activities performed for clinical trial teams. This role provides strategic data management expertise and is accountable for all end-to-end Data Management activities and deliverables pertaining to external data. The employee will provide oversight of external vendors and the data and/or data services they provide to Genmab. The External Data Lead will support the development and optimization of processes and tools to enable success of the Clinical Operations department. The employee will represent Data Management in Operational Committee’s/fora with the partners and/or DM/stat vendors. The employee will support /train colleagues in and advise on handling of external data management related processes/issues and may act as a mentor. Moreover, the employee shall support the overall strategy and development of Data Management by attending/leading task force initiatives within the department and/or as part of cross-departmental teams.
Responibilites:
Lead external data acquisition across one or more studies/programs, ensuring high-quality, timely, analysis-ready data aligned with trial objectives.Influence protocol and amendment development by advising on external data collection design, integration feasibility, and alignment with CDASH/SDTM and EDC requirements.Lead planning and oversight of external data flow strategies and DTS across diverse data types (PK/ADA, biomarker, imaging, central lab, eCOA/ePRO, PD, IRT, etc.) to ensure compliant integration.Partner with cross-functional stakeholders to ensure external data acquisition supports operational and scientific goals.Develop and manage Trial Data Integrity Plans (TDIP) and Data FlowCreate and maintain data transfer specifications (DTS) requirements. Ensure data collection requirements are aligned with external vendor capabilities and vendor data are compatible with the clinical database and SDTM requirements to support data integration, analysis and reporting. Ensure vendor data is transferred in standard data formats.Provide thorough review of external vendors budget and change orderAct as escalation point for complex vendor issues (timeline deviations, integration challenges, misalignment to trial needs).Mentor and guide junior External Data Acquisition Leads, providing direction on best practices, issue resolution, and development.Lead cross-functional initiatives including SOP development, process improvement, tools optimization, and external data standards governance.Partner with procurement/legal/vendor managers to review technical language in contracts and work orders, ensuring alignment with Genmab standards and systems.Promote portfolio-level consistency and scalability through training, knowledge sharing, and strategic planning support.Mentor and develop team members to ensure consistency of External Data Management practices.Ensure External Vendor deliverables are performed in compliance with protocol, ICH, GCP and SOPsRequirements:
Bachelor’s or Master's degree in a relevant technical area; Master’s degree preferred.10+ years of experience in external or clinical data management, with strong third-party vendor oversight and data acquisition experience.Experience working on Oncology trials/dataExperience designing and governing DTS and complex data flows supporting EDC integration and CDISC standards (CDASH, SDTM).Strong knowledge of diverse external data types (e.g., biomarker, central lab, imaging, eCOA/ePRO, genomic) and ability to align acquisition strategies to clinical and analytical objectives.Experience managing projects, vendors, and process improvements in global environments.Proven performance in earlier role.For US based candidates, the proposed salary band for this position is as follows:
$157,360.00---$236,040.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can 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!
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Read LessAt Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role
The Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of Study Data Tabulation Model (SDTM) standards, perform sponsor oversight of relevant programming activities on the Biometrics vendor, ensure the quality and consistency of data standards to support the portfolio towards the ultimate objective of data quality and consistency across programs and systems.
Responsibilities
• Develops and implements company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis.
• Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance
• Serves as a subject matter expert on all aspects of standards development that includes industry standards (CDISC), regulations, and processes
• Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity
• Directly supports knowledge development of others as a subject matter expert on data standards, reporting and analysis standards, change control management and related tools/applications
• Creates quality control processes, metrics and other measures to ensure compliance with standards
• Ensures work carried out in accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s
• Creates any needed documentation and training for standard processes, change control management and tools
• Responsible for defining standards specifications working closely with implementation support teams (database set-up, completion guidelines, CRF designers, procedures, algorithm specifications and reporting requirements)
• Facilitates a culture of continuous process improvement and a high level of customer service by maintaining and improving the standards processes associated with standards creation, maintenance, decision-making and implementation
• Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers
• Serves as a liaison between Clinical Programming and External Data Management to ensure data standardization alignment and proactively resolve external data issues that impact SDTM deliverables.
Requirements
• Bachelor’s degree in Statistics, Computer Science, Life Sciences. Master’s degree in Statistics, Computer Science, Life Sciences preferred
• At least 6-8 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency
• Proficient in SAS programming, 6-8 years experience.
• Practical knowledge and experience using R to support clinical trial preferred
• Demonstrated knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements
• Demonstrated experience managing multiple tasks, complex projects and working with cross functional teams delivering to project and portfolio timelines and metrics
• Strong verbal and written communication skills; independent and effective working in a multi-study, multi-disciplinary atmosphere in a matrix environment
• Experience in clinical data management and/or trial management experience with technical expertise in standards management and implementation is preferred.
For US based candidates, the proposed salary band for this position is as follows:
$131,040.00---$196,560.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expensesAbout Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Read LessAt Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
Key Responsibilities
Support the planning, setup, and execution of global clinical trials, ensuring activities are delivered in accordance with timelines, quality standards, and regulatory requirements.
Ensure trial oversight by maintaining accurate documentation and participating in inspection readiness activities.
Collaborate with CROs and internal stakeholders to support site feasibility, selection, activation, and ongoing site management.
Drive in the oversight of service providers, tracking deliverables, timelines, and quality to ensure alignment with study expectations.
Support risk identification and mitigation activities, contributing to risk-based quality management throughout the trial lifecycle.
Drive in managing protocol deviations and trial-level issues, ensuring proper documentation, follow-up, and escalation as needed.
Support trial data review and performance tracking, contributing to reporting and identification of potential issues.
Work collaboratively within a global, matrixed team environment, building strong relationships with internal teams, vendors, and investigators.
Qualifications
Bachelor’s degree in life sciences or related field (Master’s degree preferred).
5+ years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
Solid understanding of ICH/GCP regulations and the clinical drug development lifecycle.
Experience managing global, multi-center trials and working in a complex, matrixed organization.
Project management and service provider oversight skills.
Good communication, collaboration, and interpersonal skills.
Oncology and/or therapeutic area–specific experience is highly desirable.
For US based candidates, the proposed salary band for this position is as follows:
$119,120.00---$178,680.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can 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!
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Read LessAt Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
About the Role
At Genmab, we’re dedicated to developing and delivering innovative antibody-based therapeutics to improve the lives of patients. As a Senior Clinical Trial Manager (CTM), you will play a pivotal role in driving the success of our clinical trials through strategic oversight, operational excellence, and cross-functional collaboration.
The Senior CTM partners closely with Clinical Trial Teams (CTTs), service providers, and investigators to ensure that our clinical studies are executed on time, within budget, and in full compliance with regulatory standards and Genmab’s high-quality expectations. This role offers the opportunity to work in a dynamic, global, and matrixed environment where you will be empowered to take ownership and lead with autonomy.
Key Responsibilities
Lead the operational planning, setup, and execution of global clinical trials, ensuring delivery on time, and in compliance with regulatory and quality standards.Oversee trial documentation and systems, ensuring accuracy, completeness, and continuous inspection readiness.Drive site feasibility, selection, and activation strategies in collaboration with CROs and internal stakeholders.Manage and oversee CROs and other service providers, ensuring high-quality deliverables, adherence to timelines, and effective collaboration.Proactively identify, assess, and mitigate operational risks using risk-based quality management approaches.Oversee protocol deviations, issue management, and ensure appropriate escalation and resolution of trial-level challenges.Monitor trial performance and data quality, leveraging key metrics to drive decision-making and continuous improvement.Act as a key cross-functional leader, fostering strong collaboration across internal teams, vendors, and investigators.Qualifications
Bachelor’s degree in life sciences or related field (Master’s degree preferred).8+ years of experience in clinical trial management within the pharmaceutical or biotechnology industry.Solid understanding of ICH/GCP regulations and the clinical drug development lifecycle.Proven experience managing global, multi-center trials and working in a complex, matrixed organization.Strong project management and service provider oversight skills.Excellent communication, collaboration, and interpersonal skills.Oncology and/or therapeutic area–specific experience is highly desirable.Ability to lead without authority and mentor others in a cross-functional environment.For US based candidates, the proposed salary band for this position is as follows:
$130,720.00---$196,080.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Read LessAt Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
Position: Associate Director, Clinical Data Management
Department: Clinical Data Integration and Reporting
Reports to: Director of DM, Team Lead, Clinical Data Management
Overview
An Associate Director, Data Management can hold two roles; a “Lead Data Manager” role and/or a Data Manager role, referred to as “Data Manager”.
As “Data Manager” the employee is operationally responsible for the planning, start-up, conduct and closure of clinical trials from the point in time where a final synopsis and/or a Clinical Trial Team (CTT) is assigned.
In the “Lead Data Manager” role, the employee may act as a Data Management Lead and be responsible for the oversight and consistency across the trials within one or more development projects. The DM Lead will provide asset-level DM expertise, ensure project level standards are established and followed, and ensure consistency of DM processes across all trials within the asset. The DM Lead will provide support to trial Data Managers within the asset to ensure consistency of data management practices across the asset. When applicable, the DM Lead will provide data management expertise to the Clinical Development Team and to co-sponsor collaborations/external partners. The DM Lead will participate in and drive implementation of lessons learned and of new/innovative procedures to ensure high standards/improvement of data management related processes/systems, which may involve cross departmental stakeholders.
The employee may represent Clinical Data Management in Operational Committee’s/fora with the partners and/or DM vendors.
As Associate Director, Data Management the employee will support /train colleagues in and advise on handling of data management related processes/issues and may act as a mentor.
Moreover, the employee shall support the overall strategy and development of Clinical Data Management by attending/leading task force initiatives within the department and/or as
part of cross-departmental teams.
Responsibilities/tasks:
In the role as “Data Manager” the employee will be part of the cross-functional trial-specific Clinical Trial Team (CTT), and be responsible for delivering core deliverables such as EDC setup, data collection, validation of data in the clinical database prior to data analysis etc. within budget and timelines and according to quality standards defined by regulations/standards, Genmab SOPs and ICH-GCP. The “Data Manager” is responsible for ensuring oversight of the DM vendors and their deliverables.
The “Data Manager” is responsible for ensuring appropriate involvement of and communication with relevant stakeholders.
As Associate Director, Data Management, the employee may be involved in:
General/Trial specific:
Give input to the clinical development plans through the Development Operations representatives of the CDT ensuring that data management input/knowledge that could impact the setup and conduct of trials is proactively considered and discussed upon development of the operational strategy of the trials.Serve as Clinical Data Management representative in Operational Committee/fora with the partners, DM vendors or other vendors handling data.Participate in working groups e.g. Data protection regulation, setup of data in biomarker group, ePRO, IRT etc.Drive alignment meetings within the data management groupAttend various working groups where data management expertise is requiredProvide oversight of DM CRO including: Statement of Work; budget; KPIs; andother DM CRO trial data management activities from set up to database lockPerform vendor oversight related to key deliverables e.g. eCRF design development, review of the eCRF completion guide, UAT, approve eCRF go live, Data management plan, Data validation plan, data cleaning activities, ensuring data transfer specifications with all external data providers e.g. lab, ECG, ePRO etc. , evaluate trends in DM raised queries, ensuring final transfer of data for archiving including development of site CDs, ensuring coding listings are approved etc.Proactively participate and represent data management in the CTT and provide oversight on progression and status of related activities.Proactively discuss risks management related to data management activities in relation to trial conductReview and provide input to protocol and amendment developmentGive input to protocol deviations classifications, randomization and stratification plans, tables, figures and listings etc.Ensure procedures for blinding are in place where applicableSupport timely delivery of data management deliverables in accordance with Genmab SOP and ICH/GCPAttend trial and investigator/monitor meetings as neededParticipate in definition, review and approval of data packages for Data Monitoring Committee’s, if applicableReview and approve any corrections and updates of data packages, if applicableSupport timely development, update and maintenance of dashboards, if applicable CRO selection and collaboration:Support vendor qualification (Request for proposal, bid defense meetings etc.) in terms of Data management, ePRO and IRT related activities and define/specify scope of work for functional tasksReview scope of work in a given trial in collaboration with relevant stakeholders and review/challenge major work orders (WOs)/change orders (COs)/change notification forms (CNFs)Attend operational committee meetings, as applicable Compliance:Ensure compliance with relevant regulations, Genmab SOPs and ICH GCPEnsure escalations are made as appropriate to secure proper progress and quality of the trialEnsure compliance with Genmab Code of Business EthicsEnsure that the trial oversight activities are conducted in accordance with the trial oversight plan, e.g. ongoing review of the trial eTMF, support risk assessment analysis in the CTTs, CTT data quality review activities etc.Participate in audits and inspections as applicableEnsure timely response to audit/inspection including carrying out a comprehensive root cause analysis and share learnings across trials as applicable Project, Department and across departmental activities:Support project submission activities e.g. providing listings and documentationLead/contribute with knowledge sharing within the departmentFollow scientific, process and technical progress within the field of data management in drug development and advise of new methodologies that may support innovation and improve efficienciesContribute on processes optimizations and SOP revisionsLead cross-functional working groups/projects/task forces or new IT tools & technology implementationCompetencies
The Employee must have competences within the following areas:
Project ManagementPlanning and organizationClinical development/trial conduct, including ICH-GCPTeam leadershipExcellent communication skills and able to communicate scientific communication in clear and concise mannerProblem solving and decision makingQuality mindsetDocument creation and managementProcess developmentProactive and AccountableAnalytical and ability to interpret and present clinical dataIT skillsRequirements
Bachelor's degree in science or related area (or equivalent)
10+ years of experience in clinical data management experience in biotech/ pharma industry; significant hands-on experience in all aspects of data management.
Experience within all phases of clinical trials.
Experience with clinical trials and the drug development process
Significant experience leading data management activities in clinical trials; advanced use of data management systems; advanced knowledge of DM processes, tools, methodologies and documentation; advanced understanding of DM strategy
Experience with CDISC (SDTM); as well as data collection requirements in clinical trials
Experience and understanding of the complex and interdependent relationships between protocol development, data collection, data review and cleaning activities and analysis and reporting in clinical trials
Experience and understanding of GCPs, SOPs, regulatory requirements and good data management practices
Experience working on early and late-stage submissions as per local/regulatory requirements
Experience working in and leading cross-functional teams
For US based candidates, the proposed salary band for this position is as follows:
$157,360.00---$236,040.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Read LessAt Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role
Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.
Responsibilities/tasks – including but not limited to:
Implements and assists on developing company Study Data Tabulation Model (SDTM) standards that support the scientific need of a study/program while ensuring quality, consistency and compliance to CDISC standards and other industry standards that supports the exchange of data, reporting, and analysis
Ensures alignment of SDTM standards with data collection standards and relevant company tools/system requirements by reviewing study eCRFs, supporting creation of external data collection standards, and providing SDTM mapping guidance
Ensures study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality and integrity
Creates quality control processes, metrics and other measures to ensure compliance with standards
Ensures work carried out in accordance with applicable SOP’s and working practices, as well as global agency regulations/guidance’s
Supports developing and reviewing standard processes and templates.
Working with Digital Solutions and IT, support the implementation of future strategies and technology-enabled processes and tools for clinical trials standards, change control management and the exchange of standards information to internal downstream consumers and externally consumers
Supports development of GenSense Dashboards by providing guidance on data structure, organization and contents of the Genmab SDTM-databases to the Dashboard developers and programmers
Produce other in-house checks of data consistencies
Contributes to knowledge sharing, skill building and good collaboration with stakeholders and colleagues
Contributes to ongoing improvements in cross-functional and global collaboration and sharing of better practices and knowledge
Maintains up-to-date knowledge on relevant regulatory guidelines/requirements
Maintains a good working relationship with stakeholders and colleagues
Participates and represent clinical programming in teams and meetings
Requirements:
Bachelor’s degree in Statistics, Computer Science, Life Sciences. Master’s degree in Statistics, Computer Science, Life Sciences preferred
Has experience working in a global context
Proficient in both written and spoken English
At least 3-5 years of experience within the pharmaceutical industry
Has experience with the SAS software package
As Programming Manager, Clinical Programming, it is expected that the employee:
Acts as a role model
Leads programming study team in an effective and professional manner
Proactively engages in department activities
Arranges lessons learned to share learnings
Leads various initiatives within the department
· Proactively contributes to support a global organization
Acts as mentor for new employees or consultants
Competences and skills:
SAS programming
Analytical and problem-solving skills
Expert knowledge of the CDISC SDTM data model: the corresponding structures and organizations of the data.
Contextual understanding of the data
Writes efficient, easily maintained and well documented computer programs
Is systematic and organized in writing and archiving computer programs
Proactive and Accountable and Goal oriented
Innovative
Good team player
Good at sharing knowledge
Works independently, take responsibility and show initiative
Good communication skills
Good planning and coordinating skills
Ability to flexibly work on multiple tasks without compromise of the quality of the work
For US based candidates, the proposed salary band for this position is as follows:
$117,840.00---$176,760.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans: Critical illness, accident, and hospital indemnity insuranceTime Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leaveSupport Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being supportAdditional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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