1 день назад
Clinical Data Manager (Clinical Trials)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Data Manager (Clinical Trials): Managing clinical trial data for Phase I–III studies with an accent on data quality, regulatory compliance, and cross-functional coordination. Focus on developing clinical data management documents, reviewing discrepancies, supporting EDC and database workflows, and ensuring trial data is delivered on time and within budget.
Location: United States; remote work supported
Company
Provides consulting and clinical research solutions for biotech, medical device, and pharmaceutical organizations across the product lifecycle.
What you will do
- Serve as the primary clinical data management representative on multidisciplinary Phase I–III clinical trial teams.
- Track and communicate data management metrics, including data entry status, query resolution, and query aging.
- Review, develop, and write clinical trial documents such as Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans, and eCRF Completion Guidelines.
- Coordinate with clinical database programmers on data flow charts, data transfer specifications, and import guidelines.
- Perform data review and discrepancy resolution, support UAT and quality control activities, and archive trial documentation.
- Provide training and guidance to sites, third-party vendors, and senior clinical data coordinators.
Requirements
- At least 5 years of clinical data management experience.
- Experience with Electronic Data Capture systems is required.
- Bachelor’s degree or certification in a related allied health profession is preferred; equivalent experience may be considered.
- Knowledge of ICH/GCP and applicable local and international clinical research regulations.
- Experience in a CRO or CRO data management environment is preferred.
- Project management experience within data management is preferred.
Nice to have
- Experience with Oracle Inform EDC.
- Oncology or inflammatory therapeutic area experience.
Culture & Benefits
- Remote working is supported, with hybrid collaboration encouraged for employees located near an office.
- Inclusive workplace focused on diversity, equity, and belonging.
- Environment that encourages innovation, collaboration, and entrepreneurship.
- Applications are reviewed personally by the recruitment team rather than AI screening tools.
- Applicants receive an outcome on their application.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
4 дня назад
Director, Clinical Science (Clinical Trials)
234 190 - 287 980$
3 дня назад
Senior Biostatistician
3 дня назад
Manager, Biostatistics
3 дня назад
Director, Biostatistics (AI)
180 000 - 240 000$
5 дней назад
EClinical Coordinator (London, Entry Level)
4 дня назад
Director, Clinical Pharmacology (Oncology)
118 300 - 136 500GBP