Start Up Lead

ICON Clinical Research; España; Remote; EUR 60,000 - 95,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee Assistance Programme

Life assurance

Flexible benefits

Job summary

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%.

Qualifications

• 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%)

Responsibilities

• 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

Skills

Clinical research

Budget and contracts

Regulatory submissions

Vendor management

Team coordination

English fluency

Job description

Start Up Lead Home based Madrid

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global 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 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. Enters and updates country information in clinical and finance systems.

• Ownership of local regulatory and financial compliance. The position has a significant impacton how a country can deliver country-specific trial commitments and objectives especiallyduring study start-up.

• 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.

• Contributes to the team knowledge by acting as buddy/mentor and sharing best practices as appropriate/required

Your Profile:

5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

Required qualifications and experience:

• 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, 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.

• 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%)

What ICON can offer you:

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.

In addition to your competitive salary, ICON offers a range of additional benefits. 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.

Our benefits examples include:

• Various annual leave entitlements

• 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.

• Global 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.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. 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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)