Clinical Operations Manager, Clinical Development
Clinical Development | Santa Monica, CA | Full Time
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
We are seeking a highly motivated individual to join us as a Clinical Operations Manager. As part of this role, the incumbent will oversee all monitoring oversight activities to ensure they are compliant with ICH GCP, regional regulations, and Kite monitoring plans and SOPs. The position will report to the Vice President of Clinical Operations.
Responsibilities include but are not limited to:
- Oversee Clinical Research Associate (CRA) and all associated monitoring activities.
- Provide leadership and oversight to Clinical Research Organizations (CROs) ensuring compliance to responsibilities as outlined in the transfer of obligations and in accordance with CRO and sponsor policies, procedures, SOPs, ICH/GCP guidelines.
- Participate in the identification and evaluation of new CROs as it relates to monitoring activities.
- Provides leadership in CRO bid defense discussions and provide insight and content into contracts and scope of work.
- Implement the oversight and monitoring strategy and associated systems. Ensure individual CRAs and LCRA/CTLs are fulfilling monitoring requirements and meeting project and Kite timelines put in place to support the clinical deliverables of projects.
- Develop CRA training curriculum and study plans (including clinical monitoring plans, corrective action plans, and study training materials). Co-ordinate and preform CRA training and provide continuous update training as needed to support evolving study needs.
- Assess resourcing and CRAs workload and lead the interview, site assignment, and transition of work processes to new CRAs as applicable.
- Serves as the Kite single point of contact to the CRO for monitoring activities. When monitoring issues are identified, proactively discuss with clinical teams.
- Participate in issue escalation and governance committees for CROs, vendors, and partners.
- Develop risk based approach to review monitoring reports and conduct co-monitoring CRA assessment visits as applicable.
- Partners with senior leadership, and other applicable departments, in the development, review and implementation of departmental SOPs, business improvement / innovation initiatives.
- Develop and implement QMS for monitoring activities and create metrics, key quality and performance indicators. Leverages analytics to perform trend analysis of monitoring data and identify gaps in performance and quality.
- Report out metrics to Sr. Management and proactively identify issues and recommend opportunities to improve quality, compliance, and efficiency.
- Lead audit and inspection readiness in the monitoring function and development of root cause analysis and CAPA in response to internal audits and inspection by health authority agencies.
- Evaluate the evolving clinical research operations environment and competitive landscape, generates ideas and recommendations, and participates in quality assurance activities that foster continuous improvement across clinical monitoring process.
- Other duties as assigned.
- At minimum, a bachelor’s degree in nursing, science or health related field required.
- Seven (7) + years of related clinical trial monitoring and management experience. Highly competent knowledge of transplant patient care and apheresis collection required within at least one global region is highly desirable.
- Highly developed leadership skills
- Must be willing to travel at least 25-50% (possibly more in times of high throughput)
- Ability to deal with time demands, incomplete information or unexpected events
- Must display strong analytical and problem solving skills
- Attention to detail required
- Outstanding organizational skills with the ability to multi-task and prioritize
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10. We are able to offer the opportunity to be part of this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation. To learn more about us, please visit our website at www.kitepharma.com.
If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements. All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.
No phone calls please and no agencies or recruiters.