Associate Director, Clinical Data Management

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 group
• Attend various working groups where data management expertise is required
• Provide oversight of DM CRO including: Statement of Work; budget; KPIs; and
• other DM CRO trial data management activities from set up to database lock
• Perform 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 conduct
• Review and provide input to protocol and amendment development
• Give input to protocol deviations classifications, randomization and stratification plans, tables, figures and listings etc.
• Ensure procedures for blinding are in place where applicable
• Support timely delivery of data management deliverables in accordance with Genmab SOP and ICH/GCP
• Attend trial and investigator/monitor meetings as needed
• Participate in definition, review and approval of data packages for Data Monitoring Committee’s, if applicable
• Review and approve any corrections and updates of data packages, if applicable
• Support 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 tasks
• Review 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 GCP
• Ensure escalations are made as appropriate to secure proper progress and quality of the trial
• Ensure compliance with Genmab Code of Business Ethics
• Ensure 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 applicable
• Ensure 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 documentation
• Lead/contribute with knowledge sharing within the department
• Follow 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 efficiencies
• Contribute on processes optimizations and SOP revisions
• Lead cross-functional working groups/projects/task forces or new IT tools & technology implementation

• Excellent communication skills and able to communicate scientific communication in clear and concise manner
• Problem solving and decision making
• Quality mindset
• Document creation and management
• Process development
• Proactive and Accountable
• Analytical and ability to interpret and present clinical data
• IT skills

Requirements 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

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