Site Activation Manager / Clinical Operations Manager - Madrid

About the role

Syneos Health is looking for a Site Activation Manager / Clinical Operations Manager based in Madrid, Spain, working in a Functional Service Provider (FSP) setting. The role is accountable for performance and compliance of assigned protocols in the country, covering budget and finance, country submissions and approvals, and ensuring the site is ready.

Key responsibilities

• Own country and site budgets, negotiate and complete Clinical Trial Research Agreements (CTRA), and track clinical research payments with reconciliation at study close-out
• Oversee FCPA, DPS/OFAC compliance and maintain financial systems, and forecast budgets with SCOM and other roles
• Execute and oversee country submissions and approvals for assigned protocols, develop local-language informed consents and interact with IRB/IEC and the regulatory authority
• Manage country deliverables, timelines and results, contribute to local SOPs and oversee CTCs where applicable
• Coordinate with CRM, CTC, CRA, finance and legal, and liaise with headquarters to align country timelines
• Support and oversee local vendors, manage clinical and ancillary supplies, import/export, destruction, filing, archiving, retention and insurance, and enter country data in clinical and finance systems
• Influence investigators, partners and country operations to meet budget targets and payment timelines, and work with GCTO, finance, regulatory affairs, pharmacovigilance, legal and regional operations

Required profile

• Bachelor's degree in Business Finance, Administration, Life Sciences or equivalent health care experience
• 5 years of experience in clinical research, or combined clinical research and finance/business experience
• Excellent English skills and strong coordination and organizational skills
• Ability to work remotely in a virtual environment with a wide range of people

Required skills

• Expertise of core clinical systems, tools and metrics
• Knowledge of budget and contract negotiations, the local regulatory environment and submission/approval processes
• Strong communication, leadership, negotiation and mentoring skills in local language and English
• Proactive risk management, problem solving and independent decision-making