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.

Remote Clinical Study Associate – India

Support planning, documentation, clinical systems, and study close-out for global sponsor-dedicated trials at ICON. Work with study teams, CROs, vendors, and internal departments to coordinate trial activities.

Descriere

  • Support daily clinical study operations and inspection readiness under FSP management, following established protocols and coordinating with FSP CTA Managers.
  • Work with Clinical Operations and Study Managers, study teams, and CROs to deliver activities under the clinical trial operating model.
  • Handle departmental tasks as needed.
  • Review essential document packets, study plans, informed consent forms, and other study documentation.
  • Support and oversee risk-based monitoring.
  • Attend key team meetings and prepare minutes for selected studies.
  • Prepare for regulatory inspections, including compiling SOP lists and storyboards.
  • Support CTMS and TMF systems and related activities for selected studies.
  • Assist with vendor contract administration as required.
  • Support study close-out, including financial reconciliation.
  • Take on additional ad hoc activities as agreed with managers.
  • Coordinate with internal departments, CROs, and external vendors.

Cerințe

  • Bachelor’s degree in a scientific or healthcare-related field, or an equivalent international degree.
  • 1–2 years of experience in the pharmaceutical industry, a CRO, or a related role.
  • Experience with Phase 2 and 3 trials and global or international studies is an advantage.
  • Experience using Veeva is required.
  • Experience across multiple therapeutic areas, including oncology, is an advantage.
  • Knowledge of global or regional regulatory and compliance requirements for clinical research.
  • Strong task management and cross-functional collaboration skills.
  • Excellent communication skills.
  • Strong teamwork, organization, interpersonal, and problem-solving skills.
  • Fluent business English, written and spoken.
  • Able to collaborate in a fast-paced environment with attention to detail.
  • Willingness to travel as required, approximately 10%.
  • Must have the legal right to work in the country where the role is based.

Beneficii

  • Competitive base salary and 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.
  • Learning and development through structured training and career pathways.

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