Associate Director
1 month ago
Job Purpose: The Associate Director/Director of Clinical Data Management (CDM) will be responsible for the delivery and integrity of clinical data across Nurix's multiple studies/programs. This role may also support process development and improvement in building clinical data management infrastructure. The ideal candidate will ensure adherence to industry guidelines (including CDASH/CDISC and GCDMP) in all clinical data management activities for assigned programs/studies, as well as assisting the Head of Clinical Data Management and Head of Biometrics in the development and implementation of departmental policies, operational guidelines, and administrative structure. The successful candidate should have a successful track record in managing vendors and effectively leading program clinical data management activities with the anticipated growth in the product pipeline. They must also possess excellent communication skills to interface with leadership and study teams on behalf of the department and work closely with medical study directors and clinical operations to ensure high quality and integrity in clinical data.
Responsibilities and Duties:
Manage vendors that have been contracted to handle Nurix's clinical data and ensure the data are complete, accurate and delivered within the agreed upon timelinesEnsure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with trainingWork collaboratively with internal and external team members within the program to coordinate the planning and execution of clinical data management activitiesLead the design of the eCRFs and ensure that they align with the clinical protocol(s)Ensure complete and accurate documentation such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plansEnsure data is reviewed on an on-going basis, including individual subject data within the EDC and reconciliation with external data sourcesManage timelines for data cleaning and other CDM activities in preparation for DSURs, IBs, publications and other business needs, or final CSRsCollaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standardsAssist with establishing CDM processes and creating key CDM SOPsProvide technical leadership and guidance for other clinical data managers and vendors around project conventions, standards, practices, and database specificationsMay assist in forecasting and management of budgets for resources and program costsAct as an independent contributor to perform all clinical data management activities of an assigned program or study, as necessaryMay be required to mentor and develop direct employees and/or manage a group of internal and/or external team members, as the department growsRequired Qualifications: Bachelor's degree in a scientific discipline (computer science, mathematics, statistics, epidemiology, biology, psychology, etc.) or equivalent experienceMinimum of 15 years (for Director) or 12 years (for Associate Director) of clinical data management experience within pharmaceutical industry with a track record of success and progressionDirect experience working with Medidata Rave design and implementationDirect experience with oncology studies across multiple study phasesProficient on regulatory requirements for clinical data management and the regulatory submission processExtensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor's capabilities and ensuring the desired high-quality deliverablesExperience in managing direct reports is requiredDemonstrated ability to operate and lead in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertiseStrong team orientation; highly collaborativeSolutions and results-oriented focusHands-on approach; resourceful and open to diverse points of viewSelf-motivated and able to operate independently Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy ( ).
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