Global Study Manager II – Project Leader, FSP

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 10%

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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 study startup, database release, and inspection readiness • Oversee study management, site management, CRO, and vendor deliverables throughout the study lifecycle • Coordinate regional and country operations and provide oversight of Study Operational Managers and CRO activities • Set recruitment targets and delivery milestones and ensure execution against approved plans • Serve as a core study team member and represent the operational sub-team • Drive operational decision-making and provide input into operational strategy and protocol design • Supervise and mentor Study Operational Managers and potentially other Global Study Managers • Develop, review, and approve study startup, monitoring, recruitment, training, and other study-level plans • Oversee drug supply management and interactive randomization system setup • Manage vendor oversight, escalations, budgets, contracts, invoices, purchase orders, and cost variance • Review feasibility and pre-trial assessment outputs, approve sites, and assess site activation plans • Ensure Trial Master File setup and applicable system closure • Coordinate study and protocol training and global investigator meetings • Lead inspection readiness and site readiness activities • Support decentralized capabilities at investigator sites • Review study metrics, analytics, data reports, and dashboards to identify and mitigate risks • Resolve or triage site-level issues with cross-functional teams and CROs • Ensure compliance with SOPs, quality standards, GCPs, and study plans • Partner with data management and other departments to ensure data flow and timely delivery • Lead protocol deviation trend reviews and facilitate vendor calls • Serve as a technical expert for study management systems and processes • Champion harmonized processes, continuous improvement, quality assurance, and timely clinical trial data delivery • Identify and resolve operational staff performance issues • Support project-specific audits and inspections

🎯 Requirements

• Experience in clinical research and/or study management • Study management/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 to support global trials or initiatives • Ability to travel as required, including investigator meetings, vendor kick-off and re-set meetings, and client internal global or department-level meetings • Exceptional knowledge of study management processes and deliverables • Good understanding of responsibilities beyond the candidate’s function to ensure study goals are met • Expertise within the assigned therapeutic area and study • Working 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 in a CRO or pharma setting required • Alternatively, Master of Science or Master of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience in a CRO or pharma setting required • Scientific or technical degree preferred • Advanced knowledge of own discipline and knowledge of related disciplines

🏖️ Benefits

• Full-time employment • Remote work arrangement • Opportunity to contribute to therapies that benefit patients • Potential travel to investigator meetings, vendor meetings, and client global or department meetings