Start Up Lead Home based Madrid At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's integral expertise.
This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally. The person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.
Ownership of country and site budgets. Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Executes and oversees clinical trial country submissions and approvals for assigned protocols.
Develops local language materials including local language Informed Consents andtranslations. Responsible for quality and compliance in assigned protocols in country.
Contributes to the development of local SOPs.
Coordinates and liaises with CTM, CTA, CRA, (Finance and Legal if appropriate)



to ensurecountry deliverables are obtained for submissions, budgets, CTRAs and local milestones.
Provides support and oversight to local vendors as applicable.
Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Ownership of local regulatory and financial compliance. Required to in/directly influence investigators, external partners and country operations to adheres to budget targets and agreed payment timelines.
Works in partnership internally with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related interactions. Through cont

📌 Clinical Operations Manager/Senior Manager (La Mancha)
🏢 ICON Strategic Solutions
📍 La Mancha