Clinical Operations Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Take ownership of country and site budgets.

• Create, negotiate, and finalize Clinical Trial Research Agreements (CTRA).

• Supervise and monitor payments related to clinical research, including payment reconciliation at the conclusion of studies.

• Manage compliance with FCPA, DPS/OFAC, and maintain financial systems.

• Conduct financial forecasting in collaboration with SCOM/CRDs and other relevant roles.

• Implement and oversee clinical trial submissions and approvals for assigned protocols.

• Create local-language materials, such as informed consent forms and translations.

• Liaise with IRB/IEC and Regulatory Authorities.

• Manage deliverables, timelines, and outcomes for assigned protocols at the country level.

• Ensure adherence to quality and compliance standards in line with protocols, ICH/GCP, country regulations, and pertinent policies.

• Assist in the development of local Standard Operating Procedures (SOPs).

• Collaborate with the CTM, CTA, CRA, Finance, and Legal teams to secure country deliverables.

• Work with headquarters to synchronize country timelines.

• Provide support and oversight for local vendors.

• Coordinate local processes, including clinical and ancillary supplies, importing/exporting, destruction of supplies, filing, archiving, retention, and insurance processes.

• Input and update country data in clinical and financial systems.

• Ensure local regulatory and financial compliance.

• Influence investigators, external partners, and country operations to achieve budget goals and meet payment deadlines.

• Collaborate with country operations, finance, regulatory affairs, pharmacovigilance, legal teams, regional operations, headquarters, vendors, sites, IRB/IECs, and Regulatory Authorities.

• Provide clinical and financial contracts within fair market value.

• Contribute to or lead initiatives and projects that add business value.

• Serve as a Subject Matter Expert for processes, sharing best practices, recommending continuous improvements, and delivering training.

• Act as a buddy/mentor, sharing best practices.

⛳️ Requirements

• 5-7 years of experience in clinical research or a combination of Clinical Research and Finance/Business experience.

• Proficiency in core clinical systems, tools, and metrics.

• Exceptional verbal and written skills for influencing and training/mentoring, in both the local language and English.

• Strong organizational and coordination abilities.

• In-depth knowledge of budget and contract negotiations, the local regulatory environment, and submission and approval processes, as well as their impact on study initiation.

• Capacity to indirectly influence investigators, vendors, external partners, and country managers to resolve issues with minimal managerial support.

• Ability to make independent decisions with limited oversight from management.

• Comprehensive understanding of the local regulatory landscape.

• Proactive in developing risk management and mitigation strategies within the country and addressing issues locally.

• Willingness to travel as necessary (approximately 25%).

• Legal authorization to work in Spain.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including applicable medical, dental, and vision coverage.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.