R&D Clinical Operations Sci Assoc Prin Scientist

PepsiCo•Town/Village of Harrison, NY

5d•$93,500 - $156,450

About The Position

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.

Requirements

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 plan for site monitoring, site selection, and clinical supplies management
Excellent organizational, conflict resolution, prioritization and negotiation skills
Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
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, and Outlook
Willing to travel approximately 30% of the time

Responsibilities

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