Country Study Operations Manager I

🔥 15 minutes 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

• Support Global Study Managers and broader study management delivery by leading assigned study components, countries, and moderately complex tasks • Lead local study teams across one or more studies • Oversee preferred CROs and/or Country Trial Managers/Site Care Partners at country level • Manage country-level timelines, budgets, risks, quality plans, startup, recruitment, vendors, and site activation activities • Identify and mitigate study startup and execution risks and resolve site activation escalations • Coordinate country and investigator outreach, site identification, feasibility, recruitment planning, and milestone reporting • Ensure compliance with global and local requirements, regulations, ICH GCP standards, SOPs, and regulatory requirements • Maintain communication between global and local study teams and provide protocol-level guidance • Ensure audit and inspection readiness and manage applicable quality events • Drive data cleaning deliverables, TMF setup and completeness, IP and equipment management, and site file reconciliation • Support local vendor or facility contracting and regulatory, ethics committee, and authority submissions • Provide Investigator Meeting support, including presentations • Act as the local study team's point of contact and provide country intelligence on risks, costs, vendors, and operational practices • Support implementation of site technology systems and decentralized trial tools

🎯 Requirements

• Bachelor's of Science or Bachelor's of Arts degree with a minimum 5 years of relevant operational clinical trial experience required • Alternatively, Master's of Science or Master's of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required • A scientific or technical degree is preferred • Demonstrated clinical research and/or study management/startup project manager experience • Demonstrated experience managing country-level operational activities and/or vendors • Experience in study and quality management • Knowledge of Good Clinical Practice, clinical and regulatory operations, and 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 manage moderately complex processes, 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 as required • Ability to travel as required for Investigator Meetings, vendor meetings, and global or department meetings