Manager

• Collaborate with major functional areas across clinical trial operations and business functions
• Identify and evaluate issues related to Site Start-Up, regulatory pathways, patient enrollment, and complex data
• Ensure project deliverables meet internal and customer expectations
• Provide projections, reports, updates, and ongoing risk identification, mitigation, and management
• Develop and maintain customer relationships
• Provide oversight of project start-up deliverables from site selection through site activation and lifecycle maintenance
• Oversee regulatory activities, clinical trial agreements, investigator budgets, essential documents, and SSU timelines
• Develop plans according to SOPs and sponsor-scoped processes
• Report weekly progress and address timing risks or gaps
• Present SSU strategy and status at client meetings
• Review project SSU budgets and take corrective measures to maintain profitability
• Manage scope, timelines, resources, budgets, and out-of-scope work
• Prepare core submission documents and clinical trial application dossiers for amendments
• Perform Regulatory Impact Assessments and communicate risk mitigation
• Develop or update master SIS/ICF with Project Management and Medical departments
• Oversee country-specific application collation, quality review, and submission
• Contribute to SSU department change initiatives
• Submit relevant documents to the Trial Master File (TMF)
• Perform other assigned work-related duties

Global Site Activation Manager

• Provide strategic oversight and project management for global or multi-regional Site Activation activities
• Lead start-up delivery from pre-award through activation and lifecycle maintenance in compliance with ICH-GCP, regulatory requirements, and project timelines
• Develop and execute the Site Activation Management Plan aligned with study strategy and scope of work
• Collaborate with internal teams, regions, and external stakeholders to ensure efficient study start-up execution
• Oversee regulatory submissions, approvals, contracts, and essential document processes
• Assess regulatory landscapes and contribute to regulatory intelligence and strategy
• Identify risks and propose practical solutions to support study delivery and bid processes
• Ensure accurate tracking, reporting, and maintenance of project systems, timelines, and documentation
• Support business development, including bid defense and client engagement activities
• Mentor and coach team members and contribute to continuous improvement initiatives
• Build and maintain strong client relationships and support customer-facing activities

Site Activation Manager – Sponsor Facing

• Provide support to activities undertaken by the project team on behalf of the client and company
• Line manage assigned ICSR staff
• Create and maintain project-specific KPIs for contracted ICSR activities
• Optimize procedures, trainings and other actions to increase ICSR team efficiency
• Propose process changes to the ICSR Operational Lead
• Manage ICSR deviations with support from the ICSR Operational Lead
• Review trackers and timesheet data and ensure accuracy
• Participate in ICSR processing and second-level quality control of cases
• Support other departments as approved and instructed by the ICSR Operational Lead
• Act as the assigned team subject matter expert and support other SMEs
• Support the RA & PV Network Department as needed
• Act as LCPPV for the specified country and PRLS for the designated language, as agreed with the line manager

Manager jobs in Croatia

Global Site Activation Manager

Site Activation Manager – Sponsor Facing

Case Processing Manager, Team Lead