Associate Director, Clinical Data Manager
At Genmab, we are dedicated to building extraordinary® 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
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†.
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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.
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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.
Responsibilities:
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 timel
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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
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†.
Â
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.
Â
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.
Responsibilities:
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 timel
Apply tot his job
Apply To this Job