Intern - Development - Clinical Operations
PharmaBiotechCROClinical ResearchRegulatory Affairsgcpbiostatisticsphase iphase ivcroinform
Job description
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 Description Intern - Development - Clinical Operations As a Gilead i ntern you will contribute to high-impact meaningful projects that will not only further advance our company’s mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs. As a Gilead intern will support the planning, execution, and oversight of global clinical trials across multiple therapeutic areas. This internship provides hands-on exposure to the clinical development process, including study start-up, trial management, vendor oversight, regulatory compliance, and operational excellence initiatives. You will partner with Clinical Operations professionals and cross-functional stakeholders to gain practical experience in the execution of Phase I to Phase IV clinical studies while contributing to meaningful projects that support patient-focused drug development. Clinical Operations is responsible for the worldwide execution of clinical trials in accordance with company policies, SOPs, regulatory requirements, and Good Clinical Practice (GCP). K ey Responsibilities will include, but are not limited to the following : Support Clinical Operations teams in the planning and execution of clinical trial activities. Assist with tracking study milestones, timelines, and operational metrics. Help maintain clinical trial documentation and filing systems, including Trial Master File (TMF) quality checks. Participate in study team meetings and prepare meeting agendas, notes, and action item trackers. Assist with review and reconciliation of study-related reports and dashboards. Support vendor and CRO management activities, including follow-up on action items. Contribute to process improvement initiatives and operational excellence projects. Perform data analysis and create presentations for study teams and leadership. Learn and apply ICH-GCP guidelines and company SOPs in day-to-day activities. Collaborate with Clinical Operations, Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Clinical Supply, and other cross-functional partners. Showcase your work with a final presentation (PPT) near the conclusion of your internship Learning Objectives By the end of the internship, the intern will: Understand the clinical trial lifecycle from study start-up through closeout. Gain experience with clinical trial systems, metrics, and reporting tools. Learn how cross-functional teams collaborate to deliver clinical studies. Develop project management and organizational skills within a regulated environment. Build an understanding of regulatory requirements governing clinical research. Internship Project Examples The intern may be assigned one or more strategic projects, including: Clinical trial startup timeline analysis Country and site activation metrics review Study risk identification and mitigation tracking Clinical Operations process improvement initiatives CRO performance and operational dashboard development Inspection readiness and TMF quality improvement projects Required Qualifications: Must be at least 18 years of age at the start of the internship. Must be enrolled full‑time in a Bachelor’s, Master’s, MBA, JD or PhD program at a nationally accredited U.S. college or university, with continued full‑time enrollment required in the Fall semester following the internship. Must be currently enrolled as an undergraduate (freshman, sophomore, junior, or senior) or as a graduate/doctoral student. Must have a minimum overall cumulative GPA of 2.8 at the time of application and hire (official transcripts will be requested). Must be independently authorized to work in the United States now and in the future (current or future work authorization must not require school or employer sponsorship) official transcripts are required. Must be able to commit to a full‑time internship lasting 10–12 consecutive weeks between May and August. Must be willing and able to work at the designated site for the duration of the internship (relocation may be required). All internships are hybrid; fully remote roles are not offered. Preferred Qualifications: Preferred Degree qualification: Undergrad / Graduate Proficiency with Microsoft Office (MS Office) tools, such as Word, Excel, PowerPoint, and Outlook Strong problem‑solving skills, with the ability to identify issues and proactively seek solutions Ability to work effectively both independently and as part of a team in a collaborative environment Demonstrated commitment to inclusion and diversity, including the ability to work respectfully with individuals from diverse backgrounds Highly organized, detail‑oriented, and able to manage competing priorities in a fast‑paced environment with short timelines Currently pursuing degree in Life Sciences Public Health Nursing Pharmacy Clinical Research Health Sciences Biomedical Sciences Business or Project Management with healthcare focus Coursework or previous experience in clinical research, biotechnology, pharmaceuticals, healthcare, or life sciences. Familiarity with clinical trial processes and GCP principles. Experience working with data analysis, project tracking, or reporting tools. Ability to identify issues and seek solutions Ability to
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