Site Activation Manager – Clinical Operations Manager

🔥 5 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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