Global Study Manager II

🕒 August 10

🌐 Argentina, Mexico, +1 more countries – Remote

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

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 20%

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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 through database release and inspection readiness • Oversee regional and country operations, preferred Contract Research Organizations, and vendors • Set recruitment targets, delivery milestones, study startup, monitoring, and other study-level plans • Serve as a core team member representing the operational sub-team and drive operational decision-making with the Clinical Study Team Lead • Supervise and mentor Study Operational Managers and potentially other Global Study Managers • Develop, review, and approve study startup, monitoring, recruitment, training, and other study plans • Oversee drug supply management and interactive randomization system setup • Manage vendor oversight, escalations, contracts, work orders, expenses, invoices, and budget spend • Review feasibility outputs, pre-trial assessment reports, site approvals, and site activation plans • Ensure Trial Master File setup and applicable system closure at study completion • Coordinate study and protocol training and global investigator meetings • Monitor study delivery against approved plans, metrics, analytics, risks, and issues • Lead inspection readiness and site readiness activities • Support development and delivery of decentralized capabilities at investigator sites • Interface with CRO feasibility, study startup, monitoring, management, and site contracting groups • Work with data management and cross-functional colleagues to align data flow and delivery • Assess enrollment, discontinuations, protocol deviations, and financial forecasts • Provide operational input into protocol design and facilitate study management vendor calls • Serve as a technical expert for study management systems and processes • Champion harmonized processes, continuous improvement, quality assurance, inspection readiness, and high-quality clinical trial data • Ensure compliance with Parexel processes, ICH-GCPs, applicable requirements, training, timesheets, expense reports, and CV updates

🎯 Requirements

• Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 7 years of relevant operational clinical trial experience required • 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 with oversight of CROs and vendors • Experience managing per subject costs, vendor and ancillary costs, monitoring cost projections, and spend • 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 • Exceptional knowledge of study management processes and deliverables • Knowledge of Good Clinical Practices, monitoring, clinical operations, and regulatory operations • Expertise in the assigned therapeutic area and study • Ability to develop innovative solutions and lead complex projects • Ability to exercise independent judgment and act independently on self-initiated projects

🏖️ Benefits

• Ability to work outside of core business hours, as required, to support global trials or initiatives • Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings