Sr. Clinical Trial Management Associate

Sr. Clinical Trial Management Associate

United States - California - Santa Monica

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.

Kite, a Gilead Company, is a biopharmaceutical company that is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies.

The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Kite/Gilead’s products.

We are looking for a Senior Clinical Trials Management Associate to work within the Oncology Disease/Cell Therapy therapeutic area. This is an onsite working structure with a minimum of 3 days per week in the office.

• Assist global and regional trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
• Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
• May assist in compilation of investigator brochures under close supervision Review of trip reports generated by CRO CRAs.
• Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
• Assists in the Management of the CRO’s and vendor’s as required.
• Assists with the preparation and organization of international investigator meetings
• Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
• Performs administrative duties in a timely manner as assigned.
• Travel may be required 1 or 2 times per year (a few days).

• Master’s and 2+ years of relevant Oncology experience OR
• Bachelor’s and 4+ years of relevant Oncology experience OR
• Associate and 5+ years of relevant Oncology experience OR
• High School Diploma/GED and 6+ years of relevant Oncology experience

• Previous experience of pharmaceutical clinical trial experience
• CRA experience is highly desired
• CAR-T Cell Therapy would be desirable
• Excellent verbal, written, interpersonal and presentation skills
• Familiar with routine medical/scientific terminology.
• Proficient with Word, PowerPoint, and Excel.
• Knowledge of FDA regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Skilled in communication, time management, organization, and prioritization.
• Experience in clinical research…