Country Study Operations Manager – Clinical Trial Manager

🔥 2 hours ago

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead specific parts of clinical trial projects and drive country-level activities from study startup through conduct and closeout • Serve as leader of the local study team and coordinate core, ad hoc, and stakeholder activities • Oversee preferred CROs and Country Trial Managers/Site Care Partners for assigned studies • Manage and maintain country-level timelines, budgets, risks, and quality plans • Manage or oversee study startup activities in assigned countries • Liaise with site, regulatory, and activation partners on Health Authority and Ethics Committee submission strategy • Provide country-level input on startup and recruitment milestones • Identify and manage deviations and risks, implement mitigation strategies, and resolve site activation escalations • Support recruitment strategies, study-level plans, local communications, vendor management, quality events, protocol deviations, data issues, metrics, site risks, and audit responses • Act as point of contact for local study team questions and escalate issues when necessary • Provide local intelligence, country-level cost inputs, risk inputs, and operational guidance to global teams • Ensure Trial Master File completeness and oversight of compliance activities • Support implementation of site technology systems and decentralized trial tools • Complete required training, timesheets, expense reports, and CV updates; comply with Parexel processes, ICH-GCPs, and applicable requirements

🎯 Requirements

• 3–5 years of clinical trial study management experience required • Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial operations experience required, OR Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required • Comprehensive knowledge of own discipline and good knowledge of related disciplines • Experience managing and coordinating study management tasks and responsibilities • Working knowledge of Good Clinical Practice, clinical and regulatory operations, and country environments • Demonstrated clinical research and/or study management/startup project manager experience • Experience managing country-level operational activities and/or vendors • Experience in study and quality management • Knowledge of clinical trial methodology • Experience working in a matrix management environment • Expertise using study and site dashboards and reporting tools • Risk identification and mitigation, strategic planning, and critical path analysis skills • Analytical and problem-solving skills • Ability to adapt to changing technologies and processes, work independently, and exercise judgment • Effective verbal and written communication skills • Ability to operate in a matrix environment • Fluency in written and spoken English required • Ability to work outside core business hours when required • Ability to travel when required, including Investigator Meetings, vendor meetings, and global or department meetings • Ability to comply with Parexel processes, ICH-GCPs, and other applicable requirements