ICON plc
ICON plc
ICON plc este o organizație globală de cercetare în regim contractual, care deservește industriile din domeniul sănătății și farmaceutic. Activitatea sa cuprinde servicii clinice, de consultanță și comerciale care sprijină dezvoltarea medicamentelor, de la cercetarea timpurie până la activitățile post-comercializare. Compania oferă soluții precum studii clinice descentralizate, evaluarea siguranței cardiace, laboratoare clinice pentru etapele timpurii, imagistică medicală, informații de reglementare și dovezi din lumea reală. ICON plc dispune, de asemenea, de expertiză terapeutică în domenii precum bolile cardiovasculare, oncologia, medicina internă, terapiile celulare și genice și medicamentele biosimilare, combinând analiza datelor cu o abordare axată pe pacienți pentru a contribui la avansarea programelor clinice.

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.

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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

Locuri de muncă similare