ASSOCIATE DIRECTOR/DIRECTOR, CLINICAL DATA MANAGEMENT

Nurix

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 04/27/2021
  • Website: nurix-inc.com
  • Company Address: 1700 Owens Street Suite 500, San Francisco, CA, 94158

About Nurix

Nurix Therapeutics discovers drugs that harness the body's natural process to control protein levels.

Our drugs control ubiquitin E3 ligases, the key enzymes responsible for protein breakdown in human cells, as a unique therapeutic approach to treat a broad range of diseases.

Our focus is on developing drugs to treat cancer including novel, small molecule immuno-oncology agents.

Job Description

Nurix has a place for an extraordinary, highly motivated, self-starter and accomplished Associate Director/Director of Clinical Data Management to become a part of the growing biometrics organization.

Summary

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 remote role will also be supporting process development and improvement in building clinical data management infrastructure. The ideal candidate will ensure adherence to industry guidelines in all clinical data management activities for assigned programs, as well as assisting the Head of Biometrics in the development and implementation of departmental policies, operational guidelines, and administrative structure. They will also serve as the Clinical Data Management specialist within Global Clinical Development (GCD) and will lead the team with expertise in CDISC and GCDMP standards. 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 senior leadership and study teams on behalf of the department and work closely with medical study directors and clinical operations to provide and receive direction to ensure high quality and integrity in clinical data.

Additional key representative responsibilities will include, but not necessarily be limited to, the following:

Job Responsibilities

  • 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
  • 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, create key clinical data management SOPs
  • Provide technical leadership and guidance for clinical data management team and vendors around project conventions, standards, practices, and database specifications
  • Accountable for forecasting and management of budgets for resources and program costs
  • Hire, develop and supervise clinical data management resources, employees and consultants within area of responsibility; Sets training standards
  • Act as an independent contributor to perform all clinical data management activities of an assigned program, as necessary
  • Manages group of internal and/or external team members. Mentors and develops direct employees

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 15 years (for Director or 10 years for Associate Director) 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
  • 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 in managing direct reports is required
  • 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

Fit with Nurix Culture and Values

  • Strong team orientation; highly collaborative
  • Solutions and results-oriented focus
  • Hands-on approach; resourceful and open to diverse points of view

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.