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Lead Clinical Research Associate

Research AnalystResearch AnalystFull TimeRemoteSeniorTeam 10,001+Since 1990H1B No SponsorCompany SiteLinkedIn

Location

Romania

Posted

86 days ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglishGoogle Cloud Platform

Job Description

Lead Clinical Research Associate

ICON plc

• Oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. • Coordinate clinical trial monitoring delivery, resolving issues, and developing team capability. • Lead and oversee site management activities, including site selection, initiation, monitoring, and close-out visits, ensuring compliance with study protocols, SOPs, ICH-GCP, and applicable regulatory requirements. • Serve as the primary point of contact for the sponsor, ICON CRAs, and clinical sites, providing effective communication, resolving site-level issues, and maintaining strong site relationships to support study success. • Provide ongoing oversight of study progress through regular review of study metrics, KPIs, risks, and escalations. • Support and guide the CRA team by reviewing monitoring reports, providing regular feedback, and conducting co-monitoring visits as needed. • Work closely with the Study Manager to ensure alignment on study timelines, deliverables, and quality expectations, contributing to high-quality trial execution. • Oversee and support CRA responsibilities related to site performance and subject recruitment. • Monitor KPIs and metrics to ensure performance is within expectations, set clear site expectations, and follow up on timely and effective action plans. • Mentor and develop CRAs, supporting their professional growth and promoting consistent application of best practices across studies.

Job Requirements

  • Bachelor's degree in a relevant scientific discipline or healthcare-related field
  • Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively.
  • Extensive experience as a Senior Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials.
  • Prior experience in monitoring of cardiology & obesity clinical trials would be an advantage
  • In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
  • Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues.
  • Willingness to travel as required

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

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