Experteer Overview
As Global Study Manager, you will support delivery of clinical studies from CSP development through CSR and archiving. You’ll work cross-functionally to keep studies on time, within budget, and to quality standards, coordinating with GSD/GSAD and external partners. You will lead study document preparation, sponsor and CRO interactions, risk management, and TMF quality assurance. This is a globally connected, remote-friendly role with a focus on compliant, efficient study execution and continuous improvement. You’ll contribute to budget oversight and vendor management as part of a dedicated EMEA team.
Compensaciones / Incentivos
• Lead and contribute to delegated study documents (e.g., informed consent, master clinical study agreement) and external service provider documents
• Maintain and facilitate interactions with internal and external functions including CROs to achieve study objectives
• Contribute to planning and conduct of internal and external meetings (Investigators'/Monitors' meetings)
• Ensure supply of Investigational Product and study materials via Clinical Supply Chain or external providers
• Identify risks/issues and develop mitigation/action plans
• Ensure study documents under GSM scope are complete and QA-verified in Trial Master File
• Support GSD/GSAD with budget management (invoice reconciliation)
• Adhere to global clinical processes, ICH/GCP, and compliance manuals to ensure inspection readiness
• Support overall project management per delegation; oversee CRO Project Manager for outsourced studies with appropriate oversight
• Take on non-drug project work in process improvements or improvement projects
Responsabilidades
• University degree (or equivalent)
• At least 3 years’ experience in pharmaceutical industry or similar organization
• Knowledge of clinical development processes and various phases
• Excellent knowledge of ICH/GCP
• Strong communication and relationship-building skills, including external service provider management
• Good project management skills; ability to collaborate and work independently; demonstrated leadership
• Computer proficiency and advanced day-to-day tools
• Fluent English (verbal and written)
Requisitos principales
• remote work
• flexible work arrangements
• health and welfare benefits
• global collaboration and learning opportunities
• access to collaborative tools
• remote-friendly culture
📌 Global Study Manager - Single Sponsor dedicated (in EMEA) (Madrid)
🏢 Talent
📍 Madrid
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