Senior Director, Clinical Data Management

Nurix•Brisbane, CA

About The Position

The Senior Director of Clinical Data Management (CDM) is an extensively experienced management role responsible for the delivery and integrity of clinical data across Nurix’s multiple studies/programs. As a subject matter expert in clinical data management, this role owns the short- and long-term strategy, roadmap, budget and resource plans for the CDM function, and uses this expertise to conceive and develop new and novel ideas and infrastructure that significantly advance the function’s capabilities and performance. The ideal candidate will ensure adherence to industry guidelines (including CDASH/CDISC and GCDMP) in all clinical data management activities for assigned programs/studies and will play a leadership role—in partnership with the Head of Clinical Data Management and Head of Biometrics—in defining departmental policies, operational guidelines, and administrative structure. The successful candidate should have a successful track record managing a large or highly specialized team (including other people managers), managing vendors, and effectively leading program clinical data management activities with the anticipated growth in the product pipeline. They must also possess advanced communication skills to represent the CDM function in routine interactions with senior stakeholders, including Nurix’s Executive Management Team and external thought leaders, and to work closely with medical study directors and clinical operations to ensure high quality and integrity in clinical data.

Requirements

Bachelor’s degree in a scientific discipline (computer science, mathematics, statistics, epidemiology, biology, psychology, etc.) or equivalent experience
Minimum of 15 years of clinical data management experience within pharmaceutical industry with a track record of success and progression
Direct experience working with Medidata Rave design and implementation
Direct experience with oncology studies across multiple study phases
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
Experience managing direct reports is required, typically including some experience managing other managers
Demonstrated 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 expertise
Strong team orientation; highly collaborative
Solutions and results-oriented focus
Hands-on approach; resourceful and open to diverse points of view
Self-motivated and able to operate independently

Responsibilities

Lead and manage assigned programs, which may consist of multiple studies, ensuring alignment and consistency in data collection and processing activities
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 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 program to coordinate the planning and execution of clinical data management activities
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 and reconciliation with external data sources
Manage timelines for data cleaning and other CDM activities in preparation for DSURs, IBs, publications and other business needs, or final CSRs
Collaborate with clinical development team and provide expertise regarding CDISC data standards, FDA and ICH guidelines, and GCDMP standards
Assist with establishing CDM processes and creating key CDM SOPs
Provide technical leadership and guidance for other clinical data managers and vendors around project conventions, standards, practices, and database specifications
May assist in forecasting and management of budgets for resources and program costs
May act as an independent contributor to perform all clinical data management activities of an assigned program or study, as necessary
May be required to mentor and develop direct employees and/or manage a group of internal and/or external team members, as the department grow