Nurix, Inc. is seeking a Clinical Trial Manager (CTM)/Sr. CTM to join the Clinical Operations team. This individual will be responsible for management of assigned clinical trials and/or global regions. They will lead study team, vendors, clinical monitors and clinical sites throughout the life cycle of a clinical trial.
This individual will be able to manage clinical regions and/or trial(s) and have broad involvement in work central to Nurix’s strategic goals. They will apply existing technical skills, learn new skills, and play a key role in clinical development of the programs.The CTM/Sr. CTM is responsible for the successful implementation of assigned clinical trial(s), independently, from start-up to close-out. Experience in managing cross-functional teams, vendor oversight, knowledge of applicable regulatory requirements and developing junior staff will be essential to the team's success.
The CTM/Sr. CTM will represent Clinical Operations at Project team meetings and may represent Nurix at professional events.
Job Responsibilities:
- Accountable for all operational aspects of assigned clinical trial(s) and/or geographical region.
- Develop and implement clinical trial protocols, including study objectives, inclusion/exclusion criteria, and data collection procedures
- Responsible for selection of vendors/CROs and provide effective ongoing management and oversight to vendors/CROs to ensure compliance and execution of deliverables within the approved budget, study timeline, and study protocol
- Works closely with investigative site personnel, CROs, and other study vendors
- Manage relationships with site investigators and study coordinators
- Monitor and track clinical trial progress and provide status update to stakeholders
- Monitor recruitment progress and effectively address enrollment challenges
- Manage study contracting, budget, forecasting, accruals and payment process for all clinical trial vendors including investigational sites
- Collaborate with Data Management to ensure correct CRFs content is collected, prepare/implement CRF completion guidelines, and coordinate delivery of data updates, listings and study reports
- Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and relevant study plans, investigator brochures and clinical study reports.
- Prepare for and manage regulatory agency audits and inspections
- Must be able to participate in cross-functional strategic initiatives under limited supervision
- Proactively identifies potential issues/risks and recommends/implements solutions
- Provides leadership to the clinical operations team working on the assigned clinical trials
Experience and Skills
- B.S./ B.A. in biological sciences with 5+ years of relevant industry experience
- Ability to travel as required for the program (25%)
- Demonstrate knowledge of FDA, EMA, ICH and GCP regulations and guidelines
- Experience managing global trials
- Experience in leading teams, including CROs, consultants and vendors
- Must display strong analytical and problem-solving skills at a project level and collaborate with colleagues to generate solutions
- Strong communication and influence skills and ability to create a clear sense of direction
- Ability to deal with time demands, incomplete information or unexpected events
- Outstanding organizational skills with the ability to work independently, multi-task and prioritize
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
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.Nurix Therapeutics, Inc.
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