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ICON plc
ICON plc
Asistență medicalăConsultanțăLogistică
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.
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Locurile de muncă ale companiei

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.

CACanadaUSStatele Unite ale AmericiiPAPennsylvaniaRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • 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.

Cerințe

  • 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.

Beneficii

  • 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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