Start Up Lead Home based Madrid At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global 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 continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value. Contribute or lead initiatives and projects adding value to the business Contributes strongly to the team and other Country Operations roles knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. 5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business Excellent verbal and written influencing and training/mentoring skills, in local language and English Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes,



and understanding of how these impact study start-up Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the manager. Requires strong understanding of local regulatory environment Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

General Employee Assistance

Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

📌 Clinical Operations Manager/Senior Manager (La Mancha)
🏢 Icon Clinical Research
📍 La Mancha