Sr. Clinical Trials Manager, Clinical Operations (Oncology)

Company: GILEAD Sciences
Location: San Mateo
Posted on: January 14, 2025

Job Description:

For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.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 Gilead and help create possible, together.Job DescriptionCLINICAL OPERATIONS: -Clinical Operations 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 Development Operations functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead's products.**This position can be based at either Parsipanny, NJ or Foster City, CA. This is NOT a remote position***RESPONSIBILITIES: -In partnership with Clinical Program Manager -or Associate Director, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelinesCommunicates with functional peers regarding project status and issues and ensure project team goals are metOversees operational aspects of assigned clinical trial(s) and oversees clinical trial conduct including study start-up, enrollment, maintenance and close-out.Prepares and/or contributes to development of study-related documents (e.g., Clinical protocols, Informed consent forms, Pharmacy Manual, Monitoring Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans, Clinical Study ReportCoordinates data review to support interim/final data analysis -Participates in study strategy development.Maintains study timelines.Contributes to development of study budget.Contributes to development of RFPs and participate in selection of CROs/vendors.Provide guidance and training to CROs, vendors such as IWRS, Central lab, eCOA, -recruitment vendors,investigators and study coordinators on study requirementsManages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management). -Proactively identifies potential study issues/risks and -recommends/implements -solutions.Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.May participates in the recruiting and hiring process for CTMs and supports their professional developmentMay -mentor other junior team membersCoaches members of a work team and ensures adherence to established guidelinesKNOWLEDGE:Demonstrated ability to be a fast learner.Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.Demonstrated analytical and problem-solving skillsComplete knowledge of Food & Drug Administration (FDA), European Medicines Agency (EMA), and other applicable national regulations, -International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.Familiar with standard medical / scientific terminology.Ability to communicate in a clear and concise manner.Ability to support a team-oriented, highly-matrixed environment.Ability to execute multiple tasks as assigned.When needed, ability to travel.EXPERIENCE:BS/BA degree in nursing, science or health related field with 6+ years of trial management experience - OR -MS/MA degree in nursing, science or health related field with 4+ years of trial management experiencePREFERRED:Extensive clinical research knowledge and cross-functional understanding of clinical trial methodologyProficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies managementHighly developed leadership skills to successfully lead a clinical study teamAbility to deal with time demands, incomplete information or unexpected eventsMust display strong analytical and problem solving skillsAttention to detailOutstanding organizational skills with the ability to multi-task and prioritizeExcellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentComfortable in a fast-paced company environment and able to adjust workload based upon changing prioritiesMeets all requirements for Clinical Trial Manager (CTM) position with demonstrable proficiency.The salary range for this position is: $143,225.00 - $185,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.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 ApplicantAccommodations@gilead.com -for assistance.For more information about equal employment opportunity protections, please view the -'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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 Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.SummaryLocation: United States - New Jersey - Parsippany; United States - California - Foster CityType: Full time

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