05 oct
|
ICON Strategic Solutions
|
España
05 oct
ICON Strategic Solutions
España
Start Up Lead Home based Madrid
At 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 o
📌 Clinical Operations Manager (España)
🏢 ICON Strategic Solutions
📍 España