Responsibilities

Execute Bicara’s clinical operations strategy of high-touch, patient-centered clinical trials with a strong focus on adaptive and seamless designs to support registration.
Support clinical operations team in ensuring all trial deliverables are met according to timelines, budget, operational procedures, and quality standards. Assigned responsibilities can include development of specific sections of related study documents (e.g., sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
Work closely with external collaboration partners with a focus on relationship management and efficiency
Lead the proactive identification, assessment, and management of clinical study challenges and risks.
Support the oversight of all study activities including site identification and selection, enrollment models, clinical supply planning, budget planning and trial execution.
Monitor oversight of study progress including: CRO and third-party vendors, ensuring compliance with relevant regulations and guidelines by maintaining regular contact with external vendors, including CRAs, as applicable.
Work with CRO to develop and/or revise scope of service agreements, budgets, plans and detailed timelines and ensure that performance expectations are met.
Participate in the development and authorship of study documents including protocol, investigator brochure, informed consent, etc.
Participate in Case Report Form design and user acceptance testing in partnership with Data Management as well as data monitoring over the course of the study.
Oversee study management and/or clinical development teams (CROs) to facilitate clinical development goals and achievement of study quality metrics.
Execute CRO/Third Party Oversight Activities including but not limited to: Monitoring visit report review, periodic review of data quality, review of CRO/Vendor KPIs, performing Sponsor Oversight Visits, etc.
Contribute to and/or author clinical sections of regulatory documents including Investigators’ Brochures, safety updates, and responses to Health Authority / Ethics Committee questions.

Senior Clinical Trial Manager at Bicara Therapeutics · LumiJobs

Senior Clinical Trial Manager

Responsibilities

Qualification

Required

Company

Bicara Therapeutics

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