Start Up Lead Home based MadridAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's general 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 businessContributes 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.
Contributes to the team knowledge by acting as buddy/mentor and sharing best practices as appropriate/requiredYour Profile: 5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/BusinessRequired qualifications and

experience:
Expertise of core clinical systems,



tools and metricsExcellent verbal and written influencing and training/mentoring skills, in local language and EnglishStrong coordination and organizational skillsSkilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-upAbility 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 environmentAbility to proactively develop risk management and mitigation plans in the country and resolve issues locally.
Willingness to travel as required (approximately 25%)Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.
We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

📌 Clinical Operations Manager/Senior Manager (Valencia)
🏢 130 ICR France - FRA
📍 Valencia