Overview

The Clinical Operations team oversees the review and approval of clinical trial protocols, as well as the tracking and monitoring of PEP clinical trials and their associated publications. We provide guidance and education on Good Clinical Practice (GCP) and internal processes, ensuring all studies comply with regulatory requirements. Additionally, we support study teams by managing study setup, execution, monitoring, and the development and collection of regulatory documents from a clinical operations perspective

Responsibilities

• Manage clinical trial operations to ensure cost efficiency, and quality metrics are met
• Track trial progress, including subject recruitment, and provide routine status update
• Plan, conduct, and lead monitoring visits (both in person and remote)
• Identify and resolve project issues, implementing corrective actions when necessary
• Oversee preparation, review, and finalization of study-related documents, including protocol, regulatory materials, consent forms, and study specific documentation
• Ensure adherence to ICH/GCP guidelines, local regulations, and other applicable standards
• Provide Good Clinical Practice (GCP) training for internal Life Sciences associates and external partners
• Manage relationships with external vendors, including CROs, AROs, clinical sites, labs, and IRBs
• Negotiate and review budgets, contracts, scopes of work (SOWs), and purchase orders (POs)
• Collaborate with Product Development to coordinate blinding, labeling, storage, and shipment of study products while overseeing clinical supply logistics
• Organize and lead study-specific meeting with internal and external stakeholders
• Review, contribute to, and maintain study-related documents for Ethics submissions and study conduct
• Write detailed monitoring reports and review reports from others to ensure quality and resolution of site-related issues
• Participate in the review and quality assurance of clinical trial data in case report forms (CRFs), data listings, and final reports such as approvals, consent forms, recruitment materials) study-specific documents (such as CRFs and other data collection forms) and any other trial documentation
• Travel approximately 30% of the time (both domestically and internationally)

• The expected compensation range for this position is between $85,200 - $142,650.
• Location, confirmed job-related skills and experience will be considered in setting actual starting salary.
• 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/PhD Degree in scientific discipline with at least 4 years of clinical trials operations experience
• Strong understanding of ICH/GCP guidelines and regulatory requirements
• Excellent communication skills to effectively disseminate information to project team and outside parties
• Experience developing trial plans including developing plan for site monitoring, site selection, and clinical supplies management
• Extensive clinical research knowledge and understanding of clinical trial methodology
• Experience in decentralized, remote and real world evidence studies monitoring
• Excellent organizational, conflict resolution, prioritization and negotiation skills
• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partner
• Ability to handle a high volume of highly complex tasks within a given timeline
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, Teams and Outlook
• Willing and able to travel approximately 30% of the time (both domestically and internationally