Job Title: Senior Clinical Trial Manager
Location: San Diego, CA
About Us: We are collaborating with a pioneering biotech company specializing in NK cell therapy to revolutionize the scalability and cost-effectiveness of autoimmune drug treatments. With a seasoned leadership team and a robust pipeline of early-phase trials, we are on the cutting edge of medical innovation. We are seeking a Senior Clinical Trial Manager to join our dynamic team and drive continuous progress in our mission to improve patient outcomes.
Position Overview: The Senior Clinical Trial Manager will oversee the planning, execution, and management of clinical trials. This role requires a strategic thinker with strong leadership skills and extensive experience in clinical trial management. The ideal candidate will ensure that trials are conducted in compliance with regulatory requirements and company standards, while maintaining the highest level of quality and efficiency.
Key Responsibilities:
- Lead the planning and execution of clinical trials from start to finish.
- Develop and manage trial budgets, timelines, and resources.
- Ensure compliance with all regulatory requirements, including FDA, ICH-GCP, and other relevant guidelines.
- Oversee the selection and management of clinical trial sites and vendors.
- Collaborate with cross-functional teams, including clinical operations, data management, biostatistics, and regulatory affairs.
- Monitor trial progress and implement corrective actions as needed.
- Prepare and present trial updates to senior management and stakeholders.
- Mentor and train junior staff members.
Qualifications:
- Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred).
- Minimum of 3 years of experience in clinical trial management, with at least 1 years in a senior or lead role.
- In-depth knowledge of clinical trial processes, regulations, and best practices.
- Strong leadership and project management skills.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in clinical trial management software and tools.
Benefits:
- Competitive salary and performance-based bonuses.
- Comprehensive health, dental, and vision insurance.
- 401(k) with company match.
- Generous paid time off and holidays.
- Professional development opportunities.
- A collaborative and supportive work environment.
