**For Current Kite Pharma Employees and Contractors:** Please log onto your Internal Career Site at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld to apply for this job **Job Description** We are seeking a highly motivated individual to join us as a **_Clinical Trials Manager-Clinical Operations_** . You will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to the Program Manager of Clinical Operations. NOTE: This position can be located onsite in Santa Monica, CA, Foster City, CA, Seattle, WA or can be remote ( _with previous remote experience_ ). Responsibilities include but are not limited to: + Oversees all operational aspects of assigned clinical trial(s). + Oversees clinical trial conduct including study start-up, enrollment, study conduct and close-out. + Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). Provides oversight and guidance if some tasks are delegated to a Clinical Trials Specialist. + Participates in study strategy development, Line Listing Review, and Clinical Study Report preparation, as appropriate. + Manages the study project plan, including timelines and budget. + Provides training and manages CRO vendors such as IVRS, Central lab, Imaging. + Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met. + Further manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files). Creates and implements corrective action plan when performance expectations are not being met. + Proactively identifies potential study issues/risks and recommends/implements solutions. + Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Prepares metrics and updates for management, as assigned. + Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings. + Reviews site study documents (informed consent template and study tools/worksheets). + Serves as a liaison and resource for investigational sites. + Participates in the development, review and implementation of departmental SOPs and processes. + Attends cross-functional meetings as needed to represent Clinical Operations and study-specific issues. + Provides mentorship and career development to direct reports. + Other duties as assigned. Requirements: + At minimum, a bachelor's degree in nursing, science or health related field required + At least 5 years of related **_oncology clinical trial management_** experience on the sponsor side. + Highly competent knowledge of transplant patient care and apheresis collection a plus. + Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology + Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management + Highly developed leadership skills to successfully lead a clinical study team + Must be willing to travel at least 25% (possibly more) + Must have previous remote experience to be considered for remote role. + 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 \#LI-JK2 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 . **For jobs in the United States:** As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance. For more information about equal employment opportunity protections, please view the 'EEO is the Law' at http://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT at http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT at http://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf PAY TRANSPARENCY NONDISCRIMINATION PROVISION at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Kite Pharma Employees and Contractors:** Please log onto your Internal Career Site at https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld to apply for this job. **Change The World With Us** Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and ourday-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted. While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.