Global Study Manager II

🔥 1 hour ago

🌐 Argentina, Mexico, +1 more countries – Remote

🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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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 and coordinate global clinical trial execution from sourcing strategy and study specification development through database release and inspection readiness • Oversee regional and country operations, preferred CROs, vendors, and delegated Study Operational Managers • Set recruitment targets, delivery milestones, study startup, monitoring, training, and other study-level plans • Represent the operational sub-team on the core study team and drive operational decision-making with the Clinical Study Team Lead • Supervise and mentor Study Operational Managers and potentially other Global Study Managers • Approve and oversee drug supply management and interactive randomization system setup • Manage vendor oversight, escalations, contracts, work orders, invoices, purchase orders, and budget spend • Ensure country feasibility, site approval, site activation planning, and Trial Master File setup • Coordinate study and protocol training and global investigator meetings • Review study metrics, analytics, data reports, dashboards, enrollment, discontinuations, and protocol deviation trends • Lead inspection readiness, site readiness, study closure, and release of resources • Interface with CRO feasibility, study startup, monitoring, management, and site contracting groups • Partner with data management and cross-functional teams to ensure data flow and timely delivery • Serve as a technical expert for study management systems and processes • Support audits, inspections, quality assurance, performance feedback, and operational issue resolution • Comply with Parexel training, timesheet, expense-reporting, CV-update, process, ICH-GCP, and other applicable requirements

🎯 Requirements

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required • Alternatively, Master’s of Science or Master’s of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required • Experience in clinical research and/or study management • Study management and leadership experience • Experience overseeing CROs and vendors • Experience managing per-subject costs, vendor and ancillary costs, monitoring cost projections, and spend • Exceptional knowledge of study management processes and deliverables • Knowledge of responsibilities beyond the candidate’s own function to ensure study goals are met • Expertise in the assigned therapeutic area and study • Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory operations • Exceptional knowledge of own discipline and advanced knowledge of others • Ability to develop ideas and lead complex projects • Ability to develop innovative solutions to complex problems • Ability to exercise independent judgment and act independently on self-initiated projects • Fluency in written and spoken English required • Ability to work outside core business hours as required to support global trials or initiatives • Ability to travel as required • Scientific or technical degree preferred

🏖️ Benefits

• Ability to work remotely • Opportunities to participate in investigator meetings, vendor kick-off and re-set meetings, and client internal global or department-level meetings • Professional development through complex projects, innovation, continuous improvement, and subject matter expertise