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.
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.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- 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.