Senior Clinical Data Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Senior Clinical Data Manager: Managing all aspects of clinical trial data management process from study startup to post-database lock with an accent on database development, testing, data quality control, and oversight. Focus on developing CRF specifications, edit checks, query management, and ensuring compliance with SOPs, regulatory guidelines, and timelines.
Location: Remote, China
Company
Precision for Medicine is a CRO integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, expanding in Asia Pacific.
What you will do
- Serve as primary Data Management contact (Lead DM) for assigned projects, ensuring backup, continuity, and timely task execution.
- Oversee data entry processes, including guidelines development, training, quality control, and resourcing.
- Develop CRF specifications, coordinate database builds, UAT testing, and edit check specifications.
- Review and query clinical trial data, perform line listings, medical coding, SAE/AE reconciliation, and metric reporting.
- Liaise with sponsors, vendors, and teams on data-related issues; troubleshoot operational problems.
- Train personnel on CRF, EDC, and project items; contribute to SOPs, proposals, and cross-functional initiatives.
Requirements
- Bachelor's degree or equivalent related experience
- 8+ years of experience in clinical data management
- Professional use of English (written and oral)
- Experience with clinical database systems like Medidata Rave and Veeva
- Broad knowledge of drug/device/biologic development and data management practices
- Strong organizational, communication, leadership, and interpersonal skills
- Ability to undertake occasional travel
Nice to have
- Experience in clinical, scientific, or healthcare discipline
- Dictionary medical coding (MedDRA, WHODrug)
- Understanding of CDISC standards (CDASH, SDTM, ADaM)
- Oncology and/or Orphan Drug therapeutic experience
- Knowledge of Biostatistics
Culture & Benefits
- Work in a growing organization focused on innovative technologies and operational scale in life sciences.
- Opportunity to integrate clinical execution with scientific and data expertise.
- Equal Opportunity Employer with accommodations for disabilities.
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