Nurix is seeking a Senior Clinical Trial Manager to join the Clinical Operations team. This individual will be responsible for management of global regions and/or clinical programs. 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 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. As an early hire, they'll be influential in championing and developing Nurix's culture.
The Senior Clinical Trial Manager is responsible for the successful implementation of a clinical trial, 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 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) or geographical region.
- 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
- Monitor and track clinical trial progress and provide status update to stakeholders
- 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, investigator brochures and clinical study reports.
- 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 program
Experience and Skills:- B.S./ B.A. in biological sciences, advanced degree preferred with 5-10 years of relevant industry experience
- Ability to travel as required for the program (10-15%)
- Demonstrated knowledge of FDA, ICH and GCP regulations and guidelines
- 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
Salary Range: 172K - 199K plus bonus and equity.
