ICON plc
ICON plc
ICON plc is a global contract research organisation serving the healthcare and pharmaceutical industries. Its work spans clinical, consulting, and commercial services that support drug development from early research through post-marketing activities. The company provides solutions including decentralised clinical trials, cardiac safety, early clinical laboratories, medical imaging, regulatory intelligence, and real-world evidence. ICON plc also brings therapeutic expertise to areas such as cardiovascular disease, oncology, internal medicine, cell and gene therapies, and biosimilars, combining data analysis with patient-focused approaches to help advance clinical programmes.

Clinical Operations Manager – Spain (Remote)

Lead country-level clinical trial operations for ICON plc in Spain, managing budgets, submissions, compliance, contracts and site readiness. Support sponsor-dedicated research programs from start-up through close-out while coordinating internal teams, vendors, investigators and authorities.

Description

  • Manage country and site budgets
  • Draft, negotiate and finalize Clinical Trial Research Agreements (CTRAs)
  • Monitor clinical research payments and reconcile accounts at study close-out
  • Maintain FCPA, DPS/OFAC and financial systems compliance
  • Prepare financial forecasts with SCOMs, CRDs and other stakeholders
  • Lead country submissions and approval activities for assigned clinical trial protocols
  • Create local-language materials, including informed consent forms and translations
  • Liaise with IRBs/IECs and regulatory authorities
  • Track country deliverables, timelines and outcomes for assigned protocols
  • Maintain compliance with protocols, ICH/GCP, country regulations and applicable policies
  • Support the development of local standard operating procedures
  • Coordinate with CTMs, CTAs, CRAs, Finance and Legal to secure country deliverables
  • Align country timelines with headquarters
  • Support and manage local vendors
  • Coordinate country processes for clinical and ancillary supplies, import/export, destruction, filing, archiving, retention and insurance
  • Maintain country data in clinical and financial systems
  • Manage local regulatory and financial compliance
  • Influence investigators, external partners and country operations to achieve budget and payment-timing targets
  • Work with country operations, Finance, Regulatory Affairs, Pharmacovigilance, Legal, regional operations, headquarters, vendors, sites, IRBs/IECs and regulatory authorities
  • Deliver clinical and financial contracts within fair market value
  • Contribute to or lead business-value initiatives and projects
  • Serve as a process subject matter expert, share best practices, recommend improvements and provide training
  • Mentor colleagues and share best practices

Requirements

  • Bring 5–7 years of clinical research experience, or combined clinical research and Finance/Business experience
  • Demonstrate expert knowledge of core clinical systems, tools and metrics
  • Use strong verbal and written communication to influence, train and mentor in the local language and English
  • Apply excellent coordination and organizational skills
  • Bring solid knowledge of budget and contract negotiations, the local regulatory environment, submission and approval procedures, and their impact on study start-up
  • Influence investigators, vendors, external partners and country managers to resolve issues with minimal managerial support
  • Make independent decisions with limited managerial oversight
  • Understand the local regulatory environment thoroughly
  • Develop proactive country risk-management and mitigation plans and resolve issues locally
  • Be willing to travel as needed, approximately 25%
  • Have the legal right to work in Spain

Benefits

  • Competitive base salary with performance-related incentives
  • Health and wellbeing programs, including medical, dental and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programs and wellbeing resources
  • Structured learning, development and career-pathway opportunities

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