Associate Director, Clinical Data Management (Onsite)

Role Summary

The Associate Director of Clinical Data Management (CDM) will be responsible for the delivery and integrity of clinical data across Nurix’s multiple studies/programs. The role will also be supporting process development and improvement in building clinical data management infrastructure. He/She will ensure adherence to industry guidelines in all clinical data management activities for assigned studies, as well as assisting 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 study clinical data management activities with the anticipated growth in the product pipeline. He/She must also possess excellent communication skills work closely with medical study directors and clinical operations to provide and receive direction to ensure high quality and integrity in clinical data.

Responsibilities

• Lead and manage clinical data management duties and tasks for assigned clinical trial from study start up to study closeout
• Manage and provide oversight of vendors (including clinical data management CRO) that have been contracted to handle Nurix’s clinical data and ensure the data are complete, accurate and delivered within the agreed upon timelines
• Ensure inspection readiness by maintaining current documentation, adherence to industry guidelines, SOPs and compliance with training
• Work collaboratively with internal and external team members within the study to coordinate the planning and execution of clinical data management activities
• Create strategies for rapid study start and database lock to increase clinical data management productivity
• Lead 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 plans
• Ensure data is reviewed on an on-going basis, including individual subject data within the EDC, datasets, TLFs, etc. that are generated for CSRs, DSURs, IBs, and other business needs
• Collaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standards
• Help establishing CDM processes and contribute to the development of key clinical data management SOPs
• Provide technical support and guidance for clinical data management team and vendors around project conventions, standards, practices, and database specifications
• Perform budget review and guidance for clinical data management CRO for assigned trial

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent (computer science, mathematics, statistics, epidemiology, biology, psychology). A Master’s degree in a related science field is preferred
• Minimum of 10 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Associate Director level
• Minimum of 12 years of clinical data management experience within pharmaceutical industry with a track record of success and progression for Director level
• Direct experience working with Medidata Rave design and implementation
• Proficient on regulatory requirements for clinical data management and the regulatory submission process
• Extensive experience working with external vendors, including but not limited to acquisition, contracting, evaluation of vendor’s capabilities and ensuring the desired high-quality deliverables
• Demonstrated ability to operate and lead assigned study in a dynamic organization, build successful working relationships and effective stakeholder management in an environment that requires diverse educational and functional expertise
• Able to adapt quickly to the changing needs of the organization
• Able to organize multiple work assignments and establish priorities
• Excellent verbal and written communications skills; able to communicate proactively and effectively
• This is a full time onsite position located in Brisbane, CA

Skills

• CDM leadership and vendor management
• eCRF design and data management planning
• CDISC, FDA, ICH, and GCDMP standards
• Regulatory submission readiness
• Budget management for CROs

Education

• Bachelor’s degree required; Master’s preferred

Additional Requirements

• Onsite work in Brisbane, CA