19 oct
|
Icon Clinical
|
Barcelona
19 oct
Icon Clinical
Barcelona
Overview
As a Clinical Study Manager, you support sponsor-dedicated trials across Europe, delivering biosample and laboratory operations aligned with protocol and regulatory standards. You collaborate with cross-functional teams to ensure study execution, sample handling, and vendor performance meet timelines and quality goals. You oversee central and specialty laboratories, budgets, and resources while proactively addressing risks to protect data integrity. This role offers a meaningful chance to shape biosample programs within a general leader, contributing to therapies that benefit patients worldwide.
Compensaciones / Beneficios
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Responsabilidades
- Oversee planning, execution, and monitoring of clinical studies to ensure regulatory compliance, objectives, and timelines
- Lead oversight of biosample management activities: collection, processing, storage, shipment, tracking, reconciliation
- Collaborate with investigators, laboratories, vendors, biomarker teams, and internal stakeholders to support study execution
- Manage central laboratory and specialty vendor activities: oversight, issue escalation, performance monitoring, risk mitigation
- Review and support development of laboratory manuals, sample management plans, and study-specific laboratory procedures
- Monitor sample traceability, chain-of-custody, and quality metrics throughout the study lifecycle
- Develop and manage study budgets, resources, and timelines
- Lead resolution of biosample- and study-related issues (deviations, shipment delays, temperature excursions, lab queries)
- Ensure data integrity and quality through oversight, monitoring, and compliance across study activities
- Support laboratory and biosample-related training and guidance for study teams and sites
Requisitos principales
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Proven clinical study management experience with understanding of drug development and regulatory requirements
- Experience supporting biosample management activities within clinical trials
- Experience with central laboratories, specialty laboratories, and/or laboratory vendors
- Knowledge of laboratory manuals, sample management plans, traceability, and chain-of-custody processes
- Experience identifying and resolving biosample- and laboratory-related risks and issues
- Strong project management skills with ability to manage multiple priorities and stakeholders
- Excellent communication and interpersonal skills for cross-functional collaboration
- Detail-oriented with focus on quality, compliance, and operational excellence
- Desirable experience with biomarker, PK/PD, genomic, translational, or other biospecimen programs
- Excellent communication
- Cross-functional collaboration
- Detail-oriented
- Biosample management
- Central laboratory oversight
- Regulatory compliance
📌 Clinical Study Manager (Barcelona)
🏢 Icon Clinical
📍 Barcelona