Site Activation Manager – Clinical Operations Manager

• Manage performance and compliance for assigned clinical trial protocols in Spain
• Own country and site budgets
• Develop, negotiate and complete Clinical Trial Research Agreements (CTRA)
• Oversee and track clinical research-related payments and reconcile payments at study close-out
• Oversee FCPA, DPS/OFAC and financial systems maintenance
• Perform financial forecasting with SCOM and other roles
• Execute and oversee clinical trial country submissions and approvals
• Develop local-language materials, informed consents and translations
• Interact with IRB/IEC and Regulatory Authorities
• Manage country deliverables, timelines and results for assigned protocols
• Ensure quality and compliance for assigned protocols
• Contribute to local SOP development and oversee CTCs as applicable
• Coordinate with CRM, CTC, CRA, Finance and Legal to obtain country deliverables
• Collaborate with Headquarters to align country timelines
• Support and oversee local vendors
• Coordinate local processes, clinical and ancillary supplies, importing/exporting, supplies destruction, filing, archiving, retention and insurance processes
• Enter and update country information in clinical and finance systems
• Maintain local regulatory and financial compliance
• Influence investigators, external partners and country operations to meet budget targets and payment timelines
• Partner with internal country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations and HQ teams, and external vendors, sites, IRB/IECs and Regulatory Authorities
• Deliver clinical and financial contracts within fair market value

• Bachelor's Degree in Business Finance/Administration/Life Science or equivalent Health Care related experience
• 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business
• Expertise of core clinical systems, tools and metrics
• Excellent English skills
• Strong coordination and organizational skills
• Knowledge of budget and contract negotiations
• Knowledge of local regulatory environment and submission and approval processes
• Ability to influence investigators, vendors, external partners and country managers
• Ability to make decisions independently with limited oversight
• Ability to develop risk management and mitigation plans
• Strong problem-solving skills
• Strong communication, leadership, negotiation, influencing, training and mentoring skills, written and verbal, in local language and English
• Ability to manage multiple deliverables and protocols simultaneously
• Ability to work effectively in a remote virtual environment
• Willingness to work in compliance with ICH/GCP, country regulations, client policies, quality standards and adverse event reporting requirements

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition
• Total rewards program
• Inclusive culture
• Remote work arrangement