3 дня назад
Senior Clinical Data Coordinator
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Data Coordinator (Clinical Trials/Data Management): Conducting data management activities for Phase I–III clinical trials with an accent on ongoing data review, third-party data reconciliation, and clinical database quality. Focus on user acceptance testing, quality control, and maintaining data management documentation in accordance with ICH/GCP requirements.
Location: United States; remote role
Company
provides regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology consulting solutions for biotech, medical device, and pharmaceutical organizations.
What you will do
- Conduct ongoing data review for Phase I–III clinical trials.
- Reconcile third-party data streams and serious adverse events with the safety database.
- Perform User Acceptance Testing of clinical databases.
- Perform Quality Control of clinical databases.
- Maintain and update data management documentation.
- Work in accordance with ICH, Good Clinical Practices, and relevant procedures and guidelines.
Requirements
- Bachelor’s degree or certification in a related allied health profession is preferred; equivalent experience may be considered.
- At least 3 years of data management experience.
- Experience with Electronic Data Capture systems.
- Ability to conduct clinical database testing, quality control, and data reconciliation.
Nice to have
- Experience with Oracle Inform EDC.
- Oncology or inflammatory therapeutic area experience.
Culture & Benefits
- Remote working is supported.
- Employees located within a reasonably short commute of an office may work on a hybrid basis by agreement with their manager.
- Inclusive workplace focused on diversity, equity, and inclusion.
- Applications are personally reviewed by the recruitment team without AI screening tools.
- Applicants receive an outcome regarding their application.
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