Site Activation Manager – Clinical Operations Manager

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

📋 Description

• Oversee performance and compliance for designated clinical trial protocols in Spain.

• Manage country and site budgets effectively.

• Negotiate, develop, and finalize Clinical Trial Research Agreements (CTRA).

• Supervise and monitor clinical research-related payments, ensuring reconciliation at study close-out.

• Manage financial systems maintenance, including FCPA and DPS/OFAC compliance.

• Conduct financial forecasting in conjunction with SCOM and other roles.

• Implement and manage clinical trial country submissions and approvals.

• Create materials in the local language, including informed consents and necessary translations.

• Engage with IRB/IEC and Regulatory Authorities.

• Oversee country deliverables, timelines, and outcomes for assigned protocols.

• Ensure adherence to quality and compliance standards for assigned protocols.

• Assist in the development of local SOPs and supervise CTCs as necessary.

• Collaborate with CRM, CTC, CRA, Finance, and Legal teams to secure country deliverables.

• Work with Headquarters to synchronize country timelines.

• Provide support and oversight for local vendors.

• Manage local processes, including clinical and ancillary supplies, imports/exports, supply destruction, filing, archiving, retention, and insurance procedures.

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

• Uphold local regulatory and financial compliance.

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

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

• Ensure clinical and financial contracts are delivered within fair market value.

⛳️ Requirements

• Bachelor's Degree in Business Finance/Administration/Life Science or equivalent experience in Health Care.

• Minimum of 5 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 command of the English language.

• Strong organizational and coordination abilities.

• Familiarity with budget and contract negotiation processes.

• Understanding of the local regulatory environment and submission/approval procedures.

• Ability to influence investigators, vendors, external partners, and country management.

• Capacity to make independent decisions with minimal supervision.

• Skill in developing risk management and mitigation strategies.

• Strong problem-solving capabilities.

• Excellent communication, leadership, negotiation, influencing, training, and mentoring skills, both written and verbal, in local language and English.

• Competence in managing multiple deliverables and protocols concurrently.

• Ability to work effectively in a remote virtual setting.

• Commitment to working in compliance with ICH/GCP, country regulations, client policies, quality standards, and adverse event reporting requirements.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Flexible remote work arrangements.