Global Study Manager
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Overview
In this role you will lead global oncology study delivery from protocol through close-out, ensuring time, cost and quality targets are met. You will coordinate cross-functional teams and external partners to enable efficient, compliant execution across countries. You will own study documents and participate in meetings to accelerate readiness and inspection readiness. You will ensure supply readiness, manage risks, and oversee budgets and vendor performance. This role offers impact on pivotal cancer trials and collaboration across global teams.
Responsabilidades
Provide oversight of delegated study execution to meet time, cost and quality goals from protocol development through close-out
Coordinate interactions with internal functions and external providers (CROs) to enable consistent delivery across countries
Lead/contribute to preparation of delegated study documents (e.g., ICF, master Clinical Study Agreement) and external provider materials
Plan and facilitate internal and external meetings (Investigators' and Monitors' meetings) to align stakeholders
Ensure timely supply of investigational product and study materials via Clinical Supply Chain and partners
Identify risks and issues, develop mitigations, drive resolution to maintain momentum
Maintain inspection readiness by ensuring study documents are complete and comply with ICH/GCP
Support budget management and CRO project oversight to meet timelines and quality
Provide project management support to Global Study Directors/Associate Directors
Operate across multiple countries balancing local and global requirements
Requisitos principales University degree in a relevant field
3+ years of experience in pharma or academic clinical research environment
Knowledge of clinical development and drug development processes across phases and therapy areas
Excellent knowledge of ICH/GCP guidelines
Strong communication and relationship-building skills, including external service provider management
Good project management skills
Ability to collaborate and work independently
Proficiency with computers and daily tasks
Excellent English communication (verbal and written)
Excellent communication and relationship-building
collaboration and teamwork
independence and initiative
TMF/eTMF systems
EDC and data management interfaces
clinical supply planning
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