ICON plc yra pasaulinė sutartinių tyrimų organizacija, teikianti paslaugas sveikatos priežiūros ir farmacijos sektoriams. Jos veikla apima klinikines, konsultavimo ir komercines paslaugas, padedančias vykdyti vaistų kūrimą nuo ankstyvųjų tyrimų iki veiklos po pateikimo į rinką. Įmonė teikia decentralizuotų klinikinių tyrimų, širdies saugumo vertinimo, ankstyvosios klinikinės laboratorinės veiklos, medicininio vaizdinimo, reguliacinės žvalgybos ir realaus pasaulio įrodymų sprendimus. ICON plc taip pat turi terapinių sričių kompetencijos, įskaitant širdies ir kraujagyslių ligas, onkologiją, vidaus ligas, ląstelių ir genų terapijas bei biologiškai panašius vaistus. Derindama duomenų analizę su į pacientą orientuotais metodais, įmonė padeda plėtoti klinikines programas.
Senior Clinical Data Coordinator, Standards
Senior coordinator overseeing clinical trial data and standards for ICON’s sponsor-dedicated research programs. Supports data quality, compliance, reconciliation, and timely study delivery.
Aprašymas
- Plan and assess clinical trials, interpret complex medical data, and support the development of new treatments and therapies.
- Lead technically demanding clinical research activities, prioritizing quality and ongoing improvement.
- Develop and maintain data management plans and study records in line with industry standards and regulatory requirements.
- Find and resolve data inconsistencies to improve data flow and quality across the study lifecycle.
- Work with clinical operations and biostatistics teams to design and carry out study-specific data management approaches.
- Complete project work to keep studies on schedule, including filing and archiving records and sending queries to investigator sites.
- Guide junior data coordinators in data reconciliation, coding, and cleaning practices.
Reikalavimai
- Bachelor’s degree in a relevant discipline, such as life sciences or healthcare.
- Demonstrated clinical data management experience in the pharmaceutical or biotechnology industry.
- Familiarity with clinical data management tools such as Medidata, Oracle RDC, or similar systems.
- Strong attention to detail and effectiveness in a fast-paced work environment.
- Excellent communication and ability to work with cross-functional teams.
- Knowledge of regulatory guidance and standards, such as ICH-GCP, is an advantage.
- Willingness to travel as needed, approximately 5%.
- Must have legal authorization to work in the country where the role is based; employment with ICON is conditional on this.
Privalumai
- Competitive base pay and performance-based incentives.
- Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
- Retirement and pension plans.
- Life insurance and disability coverage.
- Employee assistance programs and wellbeing resources.
- Learning and development through structured training and career pathways.