ICON plc
ICON plc
ICON plc — денсаулық сақтау және фармацевтика салаларына қызмет көрсететін жаһандық келісімшарттық зерттеу ұйымы. Компанияның жұмысы бастапқы зерттеулерден бастап нарыққа шығарудан кейінгі қызметтерге дейін дәрі-дәрмек әзірлеуді қолдайтын клиникалық, консультациялық және коммерциялық қызметтерді қамтиды. ICON plc орталықтандырылмаған клиникалық зерттеулер, жүрек қауіпсіздігі, ерте клиникалық зертханалар, медициналық бейнелеу, реттеуші ақпарат және нақты өмір деректері сияқты шешімдер ұсынады. Сондай-ақ компания жүрек-қантамыр аурулары, онкология, ішкі аурулар, жасушалық және гендік терапиялар, биосимилярлар сияқты бағыттарда терапиялық тәжірибесін қолданып, клиникалық бағдарламалардың ілгерілеуіне көмектесу үшін деректерді талдауды пациентке бағдарланған тәсілдермен ұштастырады.

Senior Clinical Trial Manager (Remote, Pennsylvania)

Lead clinical trial delivery for ICON, overseeing study start-up, execution, compliance, risk management, budgets, and closeout. Partner with sponsors and study teams to deliver high-quality research programs.

Сипаттама

  • Manage assigned clinical trials from operational planning through delivery, meeting milestones, timelines, budget expectations, and quality standards.
  • Coordinate study start-up, site activation, enrollment planning, and execution through database lock.
  • Monitor study progress, monitoring activities, clinical metrics, and site performance.
  • Create and implement study oversight plans, monitoring strategies, and risk mitigation measures.
  • Resolve operational issues proactively to keep studies on track for successful delivery.
  • Maintain effective working relationships with sponsors, investigators, vendors, and cross-functional stakeholders.
  • Evaluate study performance metrics and deliver regular status reports and updates.
  • Support, mentor, and collaborate with Clinical Research Associates and other study team members.
  • Ensure trial activities meet protocol requirements, ICH-GCP guidelines, and applicable regulations.

Талаптар

  • Bachelor’s degree in life sciences, health sciences, nursing, pharmacy, or another relevant scientific discipline, or an equivalent combination of education and experience.
  • Substantial clinical trial management experience in a CRO, pharmaceutical, or biotechnology setting, with CRO experience preferred.
  • Track record of leading and delivering clinical studies from start-up through closeout.
  • Strong knowledge of clinical trial operations, ICH-GCP, and relevant regulatory requirements.
  • Experience overseeing study timelines, budgets, vendors, and cross-functional stakeholders.
  • Ability to assess risks, resolve complex operational issues, and drive study execution.
  • Previous clinical trial monitoring experience preferred.
  • Experience with global and/or complex clinical trials preferred.
  • Willingness and ability to travel up to 20%.
  • Legal authorization to work in the country where the position is based.

Артықшылықтар

  • Competitive base pay 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 training and career development opportunities.

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