Clinical Operations Manager
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Clinical Operations Manager overseeing country budgets, submissions, compliance and site readiness in Madrid. Supporting ICON’s sponsor-dedicated clinical research operations and trial start-up.
Responsibilities:
- 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
Similar Jobs
Clinical Project Manager
Clinical Project Manager overseeing pharmaceutical, biotechnology, and CRO research studies for Alira Health. Leading sponsors, clinical teams, compliance, budgets, and trial milestones.
Clinical Project Manager – Clinical Research, IT
Clinical Project Manager leading U.S. clinical research projects and digital trial technology for Alcedis, a contract research organization. Managing regulatory submissions, budgets, sites, and international teams.
Clinical Operations Strategy Lead
Clinical strategy lead shaping CenterWell’s senior-focused primary care strategy. Evaluating opportunities, building business cases, and aligning leaders across Humana’s healthcare services organization.
IT Program Manager – Clinical Applications, Strategic Initiatives, AI
Technical Program Manager developing Advocate Health’s Epic Factory AI Program and clinical application strategy. Leading complex healthcare technology initiatives, workflows, and change adoption.
VP, Clinical Operations – Transitions of Care
Clinical operations VP building Urrly’s post-discharge service line. Designing care pathways, scaling distributed clinicians, and improving outcomes for health-plan members.
Manager, Clinical Study Operations
Clinical Study Operations Manager leading teams and device-based clinical trials at Beacon Biosignals, a brain precision-medicine company. Overseeing study execution, compliance, KPIs, sponsors, and ClinOps initiatives.
Associate Director, Clinical Operations
Clinical operations leader overseeing oncology clinical trials, budgets, vendors, and cross-functional teams at Gilead. Driving development of therapies for serious diseases.
Clinical Operations Specialist
Clinical Operations Specialist managing regulatory intelligence, dashboards, and accreditation data. Supporting healthcare programs at Capella University and Strayer University.
Senior Consultant – Clinical Operations
Senior Consultant leading clinical and regulatory consulting engagements for Lumanity, a global healthcare strategy and evidence partner. Integrating analyses, managing clients and budgets, and shaping recommendations.
Manager, Clinical Operations
Clinical operations manager scaling Daymark Health’s value-based oncology care platform. Designing launch infrastructure, care workflows, and reliable execution across markets and teams.
Head of Technical Operations – Clinical Engineering
Head of Technical Operations deploying Cardiosense’s medical AI and wearable cardiac monitoring solutions. Leading hospital integrations, manufacturing operations, clinical studies, and usage analytics.
Vice President – Clinical Operations
Vice President leading clinical operations for Pyramid Healthcare’s behavioral healthcare programs. Driving compliant care, clinical strategy, performance improvement, and multi-program leadership.
Senior Manager, Clinical Quality Assurance
Clinical Quality Assurance Manager supporting GCP compliance, audits, CAPAs, and inspections. Helping Summit Therapeutics advance global oncology clinical studies and investigational therapies.
Country Clinical Quality Manager
Clinical Quality Manager overseeing quality, compliance, audits, and GCP processes for Merck’s US clinical trials. Coordinating QC, investigations, training, suppliers, and regulatory responses.
Senior Manager, Clinical Operations – Clinical Process Owner
Senior Manager owning Clinical Operations processes, SOPs, and governance at a global precision medicine research organization. Driving compliant, scalable process improvement across clinical research functions.
Senior Manager, Clinical Operations – Clinical Process Owner
Senior Manager governing and improving clinical operations processes, SOPs, and quality systems. Supporting global clinical research services for new therapeutics at Precision for Medicine.
Director, Clinical Development Operations
Director leading clinical development operations, process optimization, and global project management systems at Syneos Health. Supporting drug development and commercialization through integrated life sciences services.
Associate Director, Clinical Operations
Associate Director leading global clinical trial execution for Kite, a biopharmaceutical company developing CAR T-cell cancer immunotherapies. Managing programs, CROs, budgets, timelines, and Clinical Operations teams.
Senior Manager, Clinical Quality Assurance
Senior Manager overseeing clinical quality assurance for Elevar Therapeutics’ biotech clinical trials. Ensuring GCP compliance, audit readiness, regulatory submissions, and inspection preparedness.
Clinical Program Advisor – Clinical Operations
Clinical pharmacy advisor guiding Medicare benefit programs for Evernorth, which creates pharmacy, care, and benefit solutions. Advising clients, sales teams, and internal stakeholders on clinical operations and implementation.