Global Study Manager II – Project Leader, FSP

Parexel

. Lead and coordinate global clinical trial execution from sourcing strategy and study specification through study startup, database release, and inspection readiness .

Posted 10/5/2026full-timeRemote • CanadaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in clinical trial management, including oversight of CROs and vendors, study management processes, and compliance with Good Clinical Practices (GCPs). Proven ability to lead global clinical trials, manage budgets, and mentor operational teams while ensuring timely delivery of study objectives.

Highest-signal resume keywords

Clinical Trial ManagementCRO OversightBudget ManagementGood Clinical Practices (GCPs)Study Management Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Study ManagementOperational StrategyData AnalysisRisk MitigationVendor ManagementRecruitment Target SettingProtocol DesignDrug Supply ManagementTrial Master File SetupContinuous Improvement

Soft Skills

MentoringDecision-MakingCollaborationProblem-SolvingCommunication

Tools & Technologies

Study Management SystemsInteractive Randomization SystemsData Reporting Dashboards

Industry Keywords

Clinical ResearchPharmaceuticalRegulatory OperationsTherapeutic Area ExpertiseStudy Lifecycle Management

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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