About this opportunity
Genmab lists this Associate director, clinical data management opportunity in princeton, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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, e PRO, 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. e CRF design development, review of the e CRF completion guide, UAT, approve e CRF go live, Data management plan, Data validation plan, data cleaning activities, ensuring data
Who can apply
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