Job Details
Hybrid Position | Located in San Diego, CA
This Director of Clinical Operations will play a pivotal role in leading and supervising all activities related to clinical operations, including the management and execution of clinical trials in accordance with Good Clinical Practices (GCP) as well as in compliance with various governing regulatory agencies. This role involves overseeing participating study sites, managing vendors, ensuring compliance with regulatory guidelines, and implementing innovative processes to improve clinical trial management and deliverables.
Responsibilities:
- Overseeing clinical trial operations and ensuring compliance with GCP guidelines.
- Collaborate with and direct Contract Research Organizations, managing study execution and document development.
- Oversee data review processes, supervise Clinical Research Associates, and support audits of sites and vendors, ensuring efficient trial management.
- Lead and supervise all clinical operations, ensuring adherence to GCP guidelines and regulatory compliance.
- Utilize robust organizational skills and medical writing expertise to manage complex trial activities, including the creation of clear and comprehensive clinical documents
- Utilize project management methodologies to effectively oversee trial execution, ensuring consistent engagement with Contract Research Organizations (CROs) for timely and accurate completion of trial milestones
- Negotiate contracts and manage relationships with vendors and service providers, while partnering with study sites to ensure efficient and professional conduct
- Manage budget negotiations and control expenses to keep trials within financial constraints
- Oversee the site selection process and develop essential study documents and tools, such as protocols, consent forms, project plans, and budgets
- Participate in the creation and refinement of Clinical Operations SOPs and training materials
- Implement and maintain the Trial Master File for inspection readiness and conduct training sessions for study teams
- Provide updates to senior leadership and proactively manage project risks, recommending innovative processes to enhance trial management
- Oversee data integrity through reviews and cleaning activities, and ensure Clinical Research Associates effectively manage site operations
- Support compliance and quality through audits of sites and vendors, manage study supplies, and collaborate with other departments for resource alignment
Education/Skill:
- Bachelor s or Master s degree in a relevant scientific field
- Minimum of 10 years of clinical trial experience, including clinical trial management and clinical monitoring in pharmaceutical, biotech, or CRO setting: siRNA study experience preferred
- ICH/GCP Training
- Thorough knowledge of drug development, clinical operation processes, and procedures according to ICH/GCP and other regulatory guidelines
- Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint
- Proven ability to manage multiple projects simultaneously in a changing environment
- Proven ability to collaborate effectively with internal teams and external collaborators
- Self-motivated, comfortable working in a start-up environment where everyone contributes to achieving company goals, flexible, and innovative
- Experience managing Phase I - III trials, knowledge of clinical operations, ICH/GCP, and regulatory requirements