Senior Clinical Data Manager

Location
San Francisco, CA
Posted
Jan 20, 2022
Ref
5847440002
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.


Position

Nurix is searching for an extraordinary Sr. Clinical Data Manager who will be responsible for the delivery and integrity of clinical data across Nurix’s multiple studies/programs. 


Required Qualifications

  • Requires a Bachelor’s degree in a scientific discipline or equivalent (computer science, mathematics, statistics, epidemiology, biology, psychology).
  • Experience in clinical data management for 8+ years.
  • MediData Rave experience required.
  • Proficient on regulatory requirements for data management and the regulatory submission process
  • Effective communication skills

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
  • 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
  • Provide expertise regarding CDASH and CDISC data standards
  • Provide regular updates to cross-functional study teams regarding data management activities and study EDC metrics

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

Application Process

Nurix is an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US.


Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.