Clinical Operations Manager (Valencia)

Clinical Operations Manager (Valencia)

10 oct
|
Icon Clinical Research
|
Valencia

10 oct

Icon Clinical Research

Valencia

Start Up Lead Home based MadridAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s general expertise.As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.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.What You Will Do: Key responsibilities include:Ownership of country and site budgets. Development, negotiation and completion of ClinicalTrial Research Agreements (CTRA).Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC,



and maintenance of financial systems. Financial forecasting in conjunction with SCOM /CRDs, other roles.Executes and oversees clinical trial country submissions and approvals for assigned protocols.Develops local language materials including local language Informed Consents andtranslations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.Manages country deliverables, timelines and results for assigned protocols to meet countrycommitments. 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.Collaborates closely with Headquarter to align country timelines for assigned protocols.Provides support and oversight to local vendors as applica

📌 Clinical Operations Manager (Valencia)
🏢 Icon Clinical Research
📍 Valencia

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