ICON plc
ICON plc
ICON plc je globalna pogodbena raziskovalna organizacija, ki zagotavlja storitve za zdravstveno in farmacevtsko industrijo. Njeno delo vključuje klinične, svetovalne in komercialne storitve, ki podpirajo razvoj zdravil od zgodnjih raziskav do dejavnosti po prihodu na trg. Podjetje ponuja rešitve, kot so decentralizirane klinične raziskave, ocenjevanje srčne varnosti, laboratorijske storitve za zgodnje klinične raziskave, medicinsko slikanje, regulatorne informacije in dokazi iz resničnega sveta. ICON plc ima tudi terapevtsko strokovno znanje na področjih, kot so bolezni srca in ožilja, onkologija, interna medicina, celične in genske terapije ter podobna biološka zdravila, pri čemer združuje analizo podatkov s pristopi, osredotočenimi na paciente, da pomaga napredovati klinične programe.

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.

Opis

  • 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.

Zahteve

  • 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.

Ugodnosti

  • 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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