Director, Clinical Data Management

Genmab · Copenhagen · DKK 854,240 (stated in the posting)

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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!

• Overview:

The Director, Clinical Data Management, is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data.

The Director, DM will provide oversight to ensure that end-to-end data management activities are consistent across the portfolio. The employee will also provide input to/support Genmab clinical drug development programs to ensure data management excellence.

In conjunction with the Senior Director, DM, the Director DM contributes to and supports the strategic direction of the Clinical Data Management functional area and ensures activities and processes support the efficient and effective execution of clinical trials. They support the development of standards, provide system oversight support and support digital security strategies as well as drive/support audit/inspection readiness activities. Furthermore, it is expected that the employee will lead/support and facilitate process optimizations and process development within the department and within Clinical Operations in alignment with ICH-GCP and relevant guidelines. This includes, but is not limited to, writing and contributing to Genmab SOPs, procedures and guidelines within Clinical Operations and across functional areas.

The Director DM will also be responsible for activities related to outsourcing of DM activities. They will ensure establishment of relevant processes to ensure oversight of data management vendor partners to empower high quality standards and performance. The Director is expected to work in close collaboration with other functional areas within Development Operations and Clinical Development to support cohesive end to end DM processes across vendors.

The employees will be part of one or more Partnership Operational Committees with vendors and be responsible for review and establishment of state-of-the-art DM process improvements to build efficiencies and improve data quality of data management deliverables. 

The employee will be part of the extended DM leadership team and which supports the overall strategy for the department, defines the overall operational strategy, unified objectives and areas for development of Clinical Operations.

It is expected that the Director, DM drive work order review activities within the data management area and support program budget oversight activities.

Furthermore, the Director, DM may be responsible for leading, managing and developing employees in Clinical Data Management and to ensure that the employees competencies reflect their responsibilities, as outlined in their job descriptions. Through empowerment, they will utilize the full potential of their employees and ensure employees are held accountable for their deliverables.

On the more personal level it is important that you challenge and improve current processes and support new working methods and working styles.

• Responsibilities/tasks:

As a Director, Data Management, the employee

• Together with the Senior Director, DM and HoF DM, contributes to and drives the strategic direction of the Clinical Data Management functional area
• Contributes to the overall strategy, unified objectives and areas for development of Development Operations
• Ensures data management activities and processes support the efficient and effective execution of clinical trials. Leads/contributes to standardization activities across the portfolio
• Drives and supports development of systems and processes within Data Management
• Ensures end-to-end data management consistency across the portfolio
• Responsible for driving the selection, collaboration and oversight of vendors related to data management activities
• Drives/supports vendor qualification (Request for proposal, bid defense meetings etc.) for data management related activities and defines/specifies scope of work for functional tasks
• Establishes relevant processes to ensure oversight of data management vendor partners
• Leads/participates in audits and inspections as applicable
• Ensures timely response to audit/inspection including carrying out a comprehensive root cause analysis and share learnings across trials as applicable
• Develops and maintains expert competences within Clinical Data Management. Follows scientific, process and technical progress within the field of clinical data management and advises of new methodologies that may support innovation and improve efficiencies.
• Leads and actively contributes to development, review, implementation and improvements of departmental processes, policies, standard operating procedures, training, and work guidance as applicable.
• Acts as a role model
• Proactively engages in department activities
• Arranges lessons learned to share learnings
• Leads various initiatives within the department and across departments
• Proactively contributes to support a global organization
• Supports a continuous improvement mindset to ensure effectiveness of data management processes
• Supports the effectiveness of a global Development Operations organization using an outsourced model by developing new and “innovative” ways to work with internal and external partners
• Supports the expansion of Development Operations across sites and supports the development of Clinical Operations personnel globally.
• Supports system level risk assessment activities
• Supports ongoing review and oversight of vendor performance not limited to KPI/KQI review
• Ensures compliance with Genmab Code of Business Ethics
• Supports workorder review and budget oversight activities and process development within the department
• Acts as DM representative in various internal cross functional workstreams and initiatives

In the role of Partnership Operational Oversight Committee member, the employee:

• Supports the development of the DM partnership relationships and effective collaboration with CROs/Vendors
• Supports CRO governance by attending and actively participating in Partnership Operational Oversight Committee Meetings; communicates POC Meeting actions and decisions within ClinOps and other stakeholders
• Ensures DM operational excellence and implementation of best practices
• Ensures cross-trial consistency across studies conducted by the same DM CRO
• Ensures timely resolution of operational issues by POC; Ensures timely escalation of unresolved issues to the Steering Committee/Management
• Ensures alignment of processes between vendor and Genmab SOPs
• Leads meetings with Genmab DMs to ensure consistency and communication of issues across trials
• Ensures Partner Operational Manuals are maintained, as applicable

As a Project Data Manager Lead, the employee, if applicable:

• Ensures consistency of data management processes and data handling across trials within a project
• Ensures alignment of Trial DMs within a project by driving alignment meetings within the data management group
• Provides project-level DM expertise
• Act as Trial Data Manager support/backup
• Ensures trial related data management activities (including planning, data collection, data cleaning and database lock activities) are performed in accordance with Genmab SOP/processes and standards and ICH-GCP current regulatory requirements and other applicable regulations and guidelines
• Provides oversight of DM CRO including Work orders, budget, KPIs, and performs other DM CRO oversight activities. Ensures that the trial oversight activities are conducted in accordance with the trial oversight plan
• Reviews scope of work in a given trial in collaboration with relevant stakeholders.
• Reviews major work orders, change orders and change notification forms
• Reviews and provides input to protocol and amendment development
• Support development of the internal Genmab Data Review and Cleaning Plan
• Provides oversight of the Data Validation Plan; ensures robust electronic editing strategy of eCRF data
• Performs oversight of key DM documentation (Data Management Plan, eCRF Completion Guidelines, etc.)
• Drives Sponsor EDC acceptance testing of eCRF
• Provides DM oversight of data management conduct of the trial using GenSense (ODB)
• Drives data quality checks of clinical trial data using J-Review or other applications
• Provides DM oversight of data releases and DBLs to ensure data is ready for analysis and reporting
• Ensures oversight of DM trial documents in eTMF
• Ensures clear communication plan with stakeholders related to data management activities: ensures relevant stakeholders are informed on progress of data management related activities
• Ensures escalations are made, as appropriate, to secure proper progress and quality of the trial/program

• Competences:

The Employee must have competences within the following areas:

• Planning and organization
• Clinical development/trial conduct, including ICH-GCP
• People management and team collaboration
• Problem solving and decision making
• Problem solving and decision making
• Audit and inspection experience
• Communication
• Quality mindset
• Document creation and management
• Process development
• Proactivity and Accountability
• Analytical and ability to interpret and present clinical data
• Technical skills including EDC systems, data browsers and analytics tools, MS Office
• The Employee shall also render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor

Lead /manage employees, Data Management, the employee, if applicable:

• Manages, supervises, and develops people in Clinical Data Management to ensure
• undefined
• Ensures employee competencies reflect responsibilities, as outlined in job descriptions
• Support development of training plans and ensures ongoing training of people within data management
• Support DM functional area annual goals/objectives preparation in collaboration with DM leadership team and alignment with HoF DM
• Actively contributes to the extended DM leadership team by providing input to the overall strategy, unified objectives and areas for development
• Ensures the compliance readiness of employees in Development Operations by maintaining up to date dossiers for self and employees (i.e., timely R&U of SOPs and other required training, etc.)
• Supports the assessment of data management resources needed to support the current and future book of work across projects/activities.
• Contributes to hiring decisions of new employees within Data Management
• In the role as project data management lead the employee will be part of the cross-functional project teams

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well-being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the 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.

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