Clinical Operations Manager

🔥 9 minutes ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Own country and site budgets • Develop, negotiate and complete Clinical Trial Research Agreements (CTRA) • Oversee and track clinical research-related payments, including payment reconciliation at study close-out • Oversee FCPA, DPS/OFAC and financial systems maintenance • Perform financial forecasting with SCOM/CRDs and other roles • Execute and oversee clinical trial country submissions and approvals for assigned protocols • Develop local-language materials, including informed consents and translations • Interact with IRB/IEC and Regulatory Authorities • Manage country deliverables, timelines and results for assigned protocols • Ensure quality and compliance with protocols, ICH/GCP, country regulations and applicable policies • Contribute to local SOP development • Coordinate with CTM, CTA, 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 • Own local regulatory and financial compliance • Influence investigators, external partners and country operations to meet budget targets and payment timelines • Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters, vendors, sites, IRB/IECs and Regulatory Authorities • Deliver clinical and financial contracts within fair market value • Contribute to or lead business-value initiatives and projects • Act as a process Subject Matter Expert, share best practices, recommend continuous improvements and provide training • Act as a buddy/mentor and share best practices

🎯 Requirements

• 5-7 years of experience in clinical research or combined experience in Clinical Research and Finance/Business • Expertise of core clinical systems, tools and metrics • Excellent verbal and written influencing and training/mentoring skills, in local language and English • Strong coordination and organizational skills • Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-up • Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with minimal support from the manager • Ability to make decisions independently with limited oversight from the manager • Strong understanding of local regulatory environment • Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally • Willingness to travel as required (approximately 25%) • Legal right to work in Spain

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways