- Independently manage all components of a clinical trial, leading a cross-functional study team. The assigned clinical trial may be of high complexity or high risk.
- Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Kyverna SOPs.
- Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
- Partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct.
- Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites.
- Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.
- Manage external vendors with oversight of activities.
- Oversee implementation and maintenance of Trial Master File for inspection readiness.
- Develop study documents and tools including study, informed consent forms, project plans, budgets, study logs, templates, and other materials as needed.
- Collaborate with clinical team and vendors to develop study-specific documents, and maintenance of internal files
- Provide study status updates and reports to senior management.
- Participate in ongoing study data reviews and data cleaning activities.
- Participate in RFP and vendor selection process, working closely with Clinical Operations leadership and Finance.
- Provide oversight of the CRO related to site initiation, interim monitoring, and close-out visits, as needed.
- Develop and deliver study training to investigators, site staff, and internal staff on select study processes.
- Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
- Conduct internal meetings for assigned clinical trial(s)
- Participate in external meetings (e.g., Investigator Meetings), conferences and events.
- Train and mentor new clinical trial staff with appropriate delegation and may be responsible for dotted-line management of team members.
- Escalate study issues/risks in a timely manner with solid communication skills.
- Develop or contribute to SOP development and best practices and facilitate their implementation, as needed.
- Established Cell Therapy /CAR T study experience required.
- B.S. degree with minimum 6-8 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
- Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience highly preferred.
- Strong leadership, effective decision making, and problem-solving skills required.
- Established knowledge of clinical operations.
- Working knowledge of relevant GCPs and FDA/EMA regulations.
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
- Travel up to 50% - ability to travel domestically and internationally.
- Excellent written and verbal communication skills.
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Senior Clinical Trials Manager - Emeryville, United States - Kyverna Therapeutics
Description
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases.
Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
The Senior Clinical Trials Manager will be a key member of the Clinical Operations team, leading the successful execution of Kyverna's clinical trials.
Responsibilities:
Requirements:
This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.
This position is also eligible for bonus, benefits, and participation in Company's stock option plan.Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.
EOE/AA/Vets
