Trial Master File Operations Manager

Location
San Francisco, CA, United States
Posted
Aug 01, 2021
Ref
5368446002
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

The Trial Master File (TMF) Operations Manager is responsible for providing support to the study teams and external vendors to ensure quality TMF records are being collected and filed in a timely manner. The TMF Operations Manager ensures adherence to established TMF Plans, Standard Operating Procedures (SOPs), Corporate policies, and ICH GCP/applicable regulatory guidelines. This individual should also be able to promote a continuous state of audit readiness.

Work is generally of a critical or confidential nature, including but not limited to:
  • Assists study teams with the development of study-specific Trial Master File Plans, and the development of study specific TMF content models.
  • Oversight of TMF administration inclusive of provisioning access, training new users, and providing ongoing training for all users on new features/configurations.
  • Along with the assigned study CTA, performs QCs as needed or requested.
  • Conducts periodic quality reviews of the TMF to ensure timeliness, completeness, and filing accuracy.
  • Performs reconciliation of all TMF records, identifies findings/issues, and ensures remediation activities are performed for review closure and certificate issuance.
  • Sets up and manages document milestones when applicable and creates TMF reports as requested.
  • Leads the update of necessary SOP revisions to align with new processes related to use of the TMF system and/or new configurations.

Required Qualifications
  • The ideal candidate will have a strong work ethic, positive attitude, be professional, organized and detail oriented. This is a team-oriented position that plays an integral role in facilitating processes and procedures. They will also demonstrate the ability to handle and maintain confidential and sensitive information and work independently with minimal direction.
  • Associates Degree or Bachelor's Degree in, Life Sciences or other related area is required.
  • At least 5 years of practical experience working with various TMF systems in biotechnology or pharmaceutical industry
  • Candidate must possess excellent interpersonal, written and verbal communication skills
  • Demonstrated ability to manage projects to completion in a timely fashion
  • Highly proactive and willing to take initiative
  • Ability to maintain confidentiality
  • Excellent written and oral communication skills
  • Proficient at Adobe Acrobat, Word, PowerPoint and Excel
  • Possess a high degree of personal responsibility
  • Must remain professional and composed while multi-tasking under pressure

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.