Clinical Trials Ops Lead - Country Start-Up & Budget

130 ICR France - FRA; Madrid; Remote; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive base salary

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes and doo

Learning and development opportunities

Job summary

ICON Strategic Solutions in Madrid seeks a Start Up Lead to drive country-level startup activities within a sponsor-dedicated model. You will oversee budgets, regulatory submissions, and site readiness while ensuring compliance with ICH/GCP and local regulations.

You will partner with CTM, CTA, CRA and regional HQ to align timelines, manage local vendors, and mentor the country operations team. This remote role requires travel up to 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, and understanding of how these impact study start-up.
• Ability to indirectly influence investigators, vendors and country managers to address and resolve issues.
• 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

• 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

Skills

Clinical research

Budget management

Regulatory submissions

Influencing & mentoring

Vendor management

Travel readiness

Job description

ICON Strategic Solutions in Madrid seeks a Start Up Lead to drive country-level startup activities within a sponsor-dedicated model. You will oversee budgets, regulatory submissions, and site readiness while ensuring compliance with ICH/GCP and local regulations.

You will partner with CTM, CTA, CRA and regional HQ to align timelines, manage local vendors, and mentor the country operations team. This remote role requires travel up to 25%.