Clinical Data Management Lead
4 weeks ago
Clinical Data Management Lead
The Clinical Data Management Lead is responsible for overseeing the general conduct of project assigned tasks as the Lead Data Manager or under advisement from senior members of the Data Management Team.
Key responsibilities include:
- Managing data activities in an efficient manner and in accordance with regulations
- Developing and implementing the data correction process
- Resolving discrepancies and conducting data control activities
- Validating data and ensuring documentation and management of clinical study data is in accordance with regulations
Requirements
- BS/BA in health science, life science, information technology, or nursing AND 4 years equivalent experience OR demonstrated aptitude for the Clinical Data Manager role
- Minimum of 4 years pharmacy, clinical lab, or research related experience, study or instruction
- Experience working in CRO industry preferred
- Working knowledge of EDC studies
Skills
- Excellent organizational skills
- Strong written and verbal communication skills
- Technology proficiency including Data Management Systems
- Study documentation production and maintenance, data processing, data review
- Knowledge of clinical research including regulatory requirement, GCP/ICH Data Quality
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