R&D Clinical Operations Sci Assoc Prin Scientist

Overview We are seeking an experienced Clinical Operations professional to support the execution of clinical trials from planning through close-out. This role owns end-to-end trial delivery: timelines, budget, and quality, while ensuring full compliance with ICH/GCP and applicable regulatory requirements. The successful candidate will manage relationships with CROs, AROs, clinical sites, and IRBs; author and maintain study documents; and serve as a study coordinator/monitor for internally run studies.

This is a highly cross-functional role requiring close collaboration with Product Development, project teams, and external partners, along with strong judgment to identify and resolve issues as they arise across a portfolio of studies. Candidates should bring deep clinical trial methodology expertise along with experience in real-world evidence (RWE) and digital/decentralized study designs, reflecting the evolving nature of clinical research at PepsiCo.

Independently manages clinical trial project execution from a clinical operations perspective to ensure that trial timelines, costs, and quality metrics are met Ensure compliance with all applicable ICH/GCP/local regulations and regulatory guidelines Provide GCP training internally to R&D associates and externally to vendors and partners Manage external vendors (CROs, AROs, clinical sites, Central Labs, IRBs) Plan, execute, and lead study-specific meetings Track clinical trial progress, subject recruitment and provide status update reports Identify and resolve clinical project issues and recommend corrective actions Responsible for the preparation and finalization of project and study-related documents Serve project teams by reviewing their documents (protocols, regulatory documents such as approvals, consent forms, recruitment materials), study-specific documents (such as (e)CRFs and other data collection forms), and any other trial documentation Manage budget, contracts, SOWs and PO for external partners for clinical trials For internal PepsiCo studies, write and contribute to the writing of protocols and create, complete and maintain all study documents needed for IRB submission and study conduct Function as a study coordinator for internal studies Work with Product Development to coordinate blinding, labeling, storage and shipment of study product and oversee clinical supplies logistics Develop monitoring plans, conduct monitoring visits as required and issue reports Review monitoring reports of others to ensure quality and resolution of site-related issues Participate in the review of clinical data, data listing and final reports

The expected compensation range for this position is between $93,500 - $156,450. Location, confirmed job-related skills, experience, and education will be considered in setting actual starting salary. Your recruiter can share more about the specific salary range during the hiring process. Bonus based on performance and eligibility target payout is 10% of annual salary paid out annually. Paid time off subject to eligibility, including paid parental leave, vacation, sick, and bereavement. In addition to salary, PepsiCo offers a comprehensive benefits package to support our employees and their families, subject to elections and eligibility: Medical, Dental, Vision, Disability, Health, and Dependent Care Reimbursement Accounts, Employee Assistance Program (EAP), Insurance (Accident, Group Legal, Life), Defined Contribution Retirement Plan.

BS/MS Degree in scientific discipline with at least 5 years of clinical research experience Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management; strong clinical study management skills Experience with Real-World Evidence (RWE) studies and digital/decentralized clinical trial approaches Excellent communication skills to effectively disseminate information to project team