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About the Role

Support the execution of clinical trials from planning through close-out, owning end-to-end trial delivery including timelines, budget, and quality, while ensuring compliance with ICH/GCP and regulatory requirements. 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 role requires collaboration with Product Development, project teams, and external partners, with a focus on real-world evidence (RWE) and digital/decentralized study designs.

Responsibilities

Independently manage clinical trial project execution to ensure 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.
Prepare and finalize project and study-related documents.
Review project team documents (protocols, regulatory documents, consent forms, recruitment materials), study-specific documents ((e)CRFs, data collection forms), and other trial documentation.
Manage budget, contracts, SOWs, and PO for external partners for clinical trials.
Write and contribute to protocols for internal PepsiCo studies and create/maintain study documents for IRB submission and study conduct.
Function as a study coordinator for internal studies.
Coordinate blinding, labeling, storage, and shipment of study product with Product Development 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 listings, and final reports.

Requirements

BS/MS Degree in a scientific discipline.
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 teams and outside parties.
Experience developing trial plans including 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 teams, 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 (Word, Excel, PowerPoint, and Outlook).
Willing to travel approximately 30% of the time.

Skills

Clinical trial management
ICH/GCP compliance
Vendor management (CROs, AROs, clinical sites, IRBs)
Study document authoring and maintenance
Study coordination
Study monitoring
Budget management
Contract management
SOW management
PO management
Real-World Evidence (RWE)
Digital/decentralized clinical trial approaches
Communication skills
Organizational skills
Conflict resolution
Prioritization skills
Negotiation skills
Collaboration
Time management
Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

Location

Remote
Hybrid
Onsite

Work Type

Full-time

Experience Level

Experienced professional

Education Level

BS/MS Degree in scientific discipline

Salary/Compensations

$93,500 - $156,450
Bonus based on performance and eligibility target payout is 10% of annual salary paid out annually.

Benefits

Paid time off
Paid parental leave
Vacation
Sick leave
Bereavement leave
Medical insurance
Dental insurance
Vision insurance
Disability insurance
Health reimbursement accounts
Dependent care reimbursement accounts
Employee Assistance Program (EAP)
Accident insurance
Group legal insurance
Life insurance
Defined Contribution Retirement Plan

About the Company

PepsiCo is an Equal Opportunity Employer: Female / Minority / Disability / Protected Veteran / Sexual Orientation / Gender Identity / Age.

Equal Opportunity

Our Company will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Credit Reporting Act, and all other applicable laws, including but not limited to, San Francisco Police Code Sections 4901-4919, commonly referred to as the San Francisco Fair Chance Ordinance; and Chapter XVII, Article 9 of the Los Angeles Municipal Code, commonly referred to as the Fair Chance Initiative for Hiring Ordinance.
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
If you'd like more information about your EEO rights as an applicant under the law, please download the available EEO is the Law & EEO is the Law Supplement documents. View PepsiCo EEO Policy.
Please view our Pay Transparency Statement.