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.

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 Pepsi Co.

• 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 Pepsi Co 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, Pepsi Co 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 and outside parties
• Experience developing trial plans including developing…