Global Study Manager II

🔥 1 minute ago

🌐 Brazil, Argentina, +1 more countries – Remote

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

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 • Provide quality oversight and coordinate regional and country operations, Study Operational Managers, preferred Contract Research Organizations, and vendors • Set recruitment targets and delivery milestones and ensure delivery against agreed plans • Represent the operational sub-team on study execution matters 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-level monitoring, training, startup, recruitment, and protocol plans • Oversee drug supply management and interactive randomization system setup • Manage vendor oversight, escalations, contracts, budgets, invoices, purchase orders, and out-of-scope spend • Review feasibility outputs, pre-trial assessment reports, study metrics, and analytics to identify and mitigate risks • Form and lead the operational sub-team and request resources as needed • Ensure country feasibility, site approvals, site activation plans, and Trial Master File setup • Coordinate study and protocol training and global and local investigator meetings • Resolve or triage site-level issues with cross-functional teams and preferred CROs • Lead inspection readiness and site readiness activities • Support decentralized capabilities at investigator sites • Ensure timely study closure and release of resources after database lock • Interface with CRO feasibility, startup, monitoring, management, and site contracting groups • Partner with data management to ensure data-flow alignment and timely delivery • Review data reports and dashboards, escalate deviations, and oversee mitigations • Assess enrollment and discontinuations for financial forecasting • Provide operational input into protocol design and lead protocol deviation trend reviews • Serve as a technical expert for study management systems and processes • Champion harmonized processes, continuous improvement, issue resolution, inspection readiness, quality assurance, and study management deliverables • Partner with the operational sub-team and preferred CRO to resolve performance issues • Support project-specific audits and inspections • Complete required training, timesheets, expense reports, and CV updates while complying with Parexel processes, ICH-GCPs, and applicable requirements

🎯 Requirements

• Experience in clinical research and/or study management • Study management and leadership experience • Experience overseeing CROs and vendors • Experience managing per-subject costs and vendor, ancillary, and 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 (GCPs), monitoring, clinical operations, and regulatory operations • Bachelor of Science or Bachelor of Arts degree with a minimum 7 years of relevant operational clinical trial experience required, or Master of Science/Master of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience required • Scientific or technical degree preferred • Compliance with Parexel processes, ICH-GCPs, and other applicable requirements

🏖️ Benefits

• Ability to work remotely • Ability to travel, as required, including investigator meetings, vendor kick-off and re-set meetings, and client internal global or department level meetings