Clinical Operations

• Manage performance and compliance for assigned clinical trial protocols in Spain
• Own country and site budgets
• Develop, negotiate and complete Clinical Trial Research Agreements (CTRA)
• Oversee and track clinical research-related payments and reconcile payments at study close-out
• Oversee FCPA, DPS/OFAC and financial systems maintenance
• Perform financial forecasting with SCOM and other roles
• Execute and oversee clinical trial country submissions and approvals
• Develop local-language materials, informed consents and translations
• Interact with IRB/IEC and Regulatory Authorities
• Manage country deliverables, timelines and results for assigned protocols
• Ensure quality and compliance for assigned protocols
• Contribute to local SOP development and oversee CTCs as applicable
• Coordinate with CRM, CTC, CRA, Finance and Legal to obtain country deliverables
• Collaborate with Headquarters to align country timelines
• Support and oversee local vendors
• Coordinate local processes, clinical and ancillary supplies, importing/exporting, supplies destruction, filing, archiving, retention and insurance processes
• Enter and update country information in clinical and finance systems
• Maintain local regulatory and financial compliance
• Influence investigators, external partners and country operations to meet budget targets and payment timelines
• Partner with internal country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations and HQ teams, and external vendors, sites, IRB/IECs and Regulatory Authorities
• Deliver clinical and financial contracts within fair market value

Explore Site Activation Manager – Clinical Operations Manager at Syneos Health. Review requirements and application details.