ICON plc
ICON plc
ICON plc ir globāla līgumizpētes organizācija, kas apkalpo veselības aprūpes un farmācijas nozares. Tās darbība ietver klīniskos, konsultāciju un komerciālos pakalpojumus, kas atbalsta zāļu izstrādi no agrīnas izpētes līdz darbībām pēc zāļu nonākšanas tirgū. Uzņēmums piedāvā decentralizētus klīniskos pētījumus, sirds drošuma novērtēšanu, agrīnās klīniskās laboratorijas pakalpojumus, medicīnisko attēlveidošanu, regulatīvo informāciju un reālās pasaules pierādījumu risinājumus. ICON plc ir arī terapeitiskā kompetence tādās jomās kā sirds un asinsvadu slimības, onkoloģija, iekšķīgās slimības, šūnu un gēnu terapijas, kā arī bioloģiski līdzīgas zāles. Apvienojot datu analīzi ar uz pacientu vērstām pieejām, uzņēmums palīdz attīstīt klīniskās programmas.

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.

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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.

Saistītās vakances