Madrid-Based Clinical Start-Up Lead — Budgets & Submissions

ICON Clinical Research; España; A distancia; EUR 60.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

Employee Assistance Programme

Life assurance

Flexible benefits

Descripción de la vacante

ICON Clinical Research is seeking a Start Up Lead for Madrid (home-based) to oversee country budgets, regulatory submissions, and site readiness. You will manage CTAs, budgets, and local vendor interactions while collaborating with global teams to ensure timely study start-up across assigned protocols.

The role requires 5-7 years in clinical research with strong financial and regulatory knowledge, and a willingness to travel about 25%.

Formación

• 5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
• Expertise of core clinical systems, tools and metrics
• Excellent verbal and written influencing and training/mentoring skills, in local language and English
• Strong coordination and organizational skills
• Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes
• Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the manager
• Ability to make decisions independently with limited oversight 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
• Willingness to travel as required (approximately 25%)

Responsabilidades

• Own country and site budgets, develop and complete CTAs
• Oversee and track clinical research-related payments and reconciliation
• Execute and oversee country submissions and approvals for assigned protocols
• Develop local language materials including ICFs and translations
• Ensure country deliverables meet commitments and maintain quality/compliance
• Contribute to local SOP development
• Coordinate with CTM, CTA, CRA and other functions to obtain deliverables for submissions and budgets
• Align country timelines with HQ and collaborate with local vendors
• Provide support and oversight to local vendors
• Oversee local processes, supplies management, import/export, archiving and filing
• Own local regulatory and financial compliance and impact on study start-up
• Influence investigators and partners to meet budget targets and payment timelines
• Collaborate with internal teams and external stakeholders on submissions and approvals
• Lead or contribute to value-adding initiatives and projects
• Share knowledge as SME and provide training as needed
• Mentor and share best practices within the team

Conocimientos

Clinical research

Budget and contracts

Regulatory submissions

Vendor management

Team coordination

English fluency

Descripción del empleo

ICON Clinical Research is seeking a Start Up Lead for Madrid (home-based) to oversee country budgets, regulatory submissions, and site readiness. You will manage CTAs, budgets, and local vendor interactions while collaborating with global teams to ensure timely study start-up across assigned protocols.

The role requires 5-7 years in clinical research with strong financial and regulatory knowledge, and a willingness to travel about 25%.