Director, Study Start Up-EU
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Overview
As Director, Study Start Up-EU you lead the SSU group across the region, aligning strategy with project delivery and client expectations. You'll partner with PM, Clinical Leadership and Business Development to ensure smooth regulatory submissions, site activation and contract alignment. You drive operational excellence, manage risk, and develop staff while delivering on regional metrics. This role offers influence over process improvements, training, and cross-regional collaboration to accelerate medical innovation. You will shape how SSU supports patients by enabling timely study start-up in a complex regulatory landscape.
Responsabilidades
Lead the Study Start Up (SSU) group in the assigned region(s) and drive business strategy aligned to project delivery
Performance manage and develop SSU staff; ensure departmental utilization and staffing for new studies
Collaborate with Project Management, Clinical Leadership and Business Development to manage contractual agreements and client expectations
Oversee SSU activities: initial essential documents, EC/IRB submissions, site initiation, ethical committee submissions, and coordination with site teams
Identify global process improvements, develop training materials, and maintain consistency across the department
Manage metrics to support business initiatives and ensure timely project delivery
Provide risk management, issue escalation, and proactive problem solving for complex time-sensitive issues
Oversee SSU performance and regional teams; participate in resource planning for new studies
Partner with VP to improve, streamline, and apply global SSU efficiencies and processes
Collaborate with US and other regions to align goals and ensure proactive, contract-compliant SSU processes
Contribute to business development through evaluating proposal specifications and participating in monthly metric reporting
Mentor direct reports, oversee training and career development, and ensure smooth transition planning for staff changes
Review applicable SOPs, WGs and ADs related to SSU; share knowledge with other managers
Produce succinct internal and external documentation and presentations with minimal upper-management input
Requisitos principales Bachelor in Clinical, Scientific or Health-related field
7-9 years of related health sciences experience; clinical trials support or pharmaceutical industry preferred
Direct experience in study start up roles
5-7 years of personnel management experience overseeing larger teams
Expertise in ICH/GCP and/or ISO14155 and country-specific regulatory requirements for clinical trials
Working knowledge of FDA, European Regulatory and EC procedures
Knowledge of site and institution contract requirements
leadership
cross-functional collaboration
risk management
ICH/GCP
ISO14155
EC submissions and regulatory compliance
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