1 день назад
Lead Data Manager - FS
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Lead Data Manager - FS (Clinical Data Management): Leading end-to-end clinical data management activities, including database design, EDC setup, data validation, cleaning, reconciliation, and trial documentation, with an accent on data quality and timely study delivery. Focus on coordinating CRF reviews, managing edit-check testing and query resolution, maintaining the Trial Master File, and mentoring Data Managers.
Location: Romania
Company
provides functional services to biotech, medtech, and specialty pharma organizations developing medicines, medical devices, and diagnostics.
What you will do
- Lead end-to-end clinical data management activities, including database design, setup, CRF and non-CRF collection tools, data cleaning, and documentation.
- Prepare data management plans, data validation plans, completion guidelines, reports, and other study documents.
- Coordinate CRF reviews, database structure reviews, data validation, user acceptance testing, and edit-check implementation.
- Manage data cleaning, query and discrepancy resolution, third-party data reconciliation, and CRF tracking.
- Coordinate with Project Managers and sponsors, provide data management updates, and maintain an accurate Trial Master File throughout the study lifecycle.
- Mentor and train Data Managers; travel overnight for business purposes up to 10% of the time.
Requirements
- Bachelor’s degree or international equivalent, preferably in a technical, clinical, or health-related field, or an equivalent combination of education, training, and experience.
- 3–5 years of practical experience leading database management activities and using clinical data management systems or EDC products.
- Experience with systems such as Oracle RDC / Inform, Medidata Rave, or DataLabs.
- English proficiency is required, with excellent verbal and written communication skills.
- Strong computer skills in Microsoft Windows and proficiency with Microsoft Office.
- Ability to work independently, manage multiple projects, take ownership of deliverables, and operate effectively in a fast-paced environment with changing priorities.
Culture & Benefits
- Flexible working practices designed to support professional growth and work-life balance.
- Opportunities to develop skills and advance professionally.
- Team members are encouraged to contribute ideas and influence ways of working.
- Full-time employment focused on supporting medical innovation and patient outcomes.
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