Clinical Operations Manager

Startup 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 and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments. 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 ensure country 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 impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
• Required to in/directly influence investigators, external partners and country operations to adhere 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%)

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.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.