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Clinical Safety Data Associate
2 months ago
We are seeking a highly skilled and detail-oriented Clinical Safety Data Associate to join our team at Everest Clinical Research Services Inc. As a key member of our clinical data management team, you will be responsible for ensuring the accuracy and quality of safety data in clinical trials.
Key Responsibilities- Develop and maintain safety data review plans and checklists for clinical trial laboratory data, adverse events, and medical events of special interest.
- Perform safety data reviews according to the review plan and ensure that all issues are resolved in a timely manner.
- Coordinate with study project managers and clinical data managers to maintain high-quality data collected in clinical trials.
- Provide medical advice and support to clinical data managers as needed.
- Coding of adverse events, medical histories, and concomitant diseases using the MedDRA dictionary.
- Coding of medications using the WHODrug dictionary.
- Ensure accurate and timely coding of medical events and medications in the study database.
- Participate in trial protocol review and review of case report forms to ensure accurate and consistent approaches in laboratory data collection.
- Provide medical advice and support to clinical data managers in writing laboratory edit specifications and reviewing specifications for accuracy and completeness.
- Review and confirm laboratory normal ranges and units from central and local laboratories.
- Coordinate with clinical data managers to manage local and central laboratory data and resolve related data issues.
- Assist the director of medical coding in ensuring proper version control of coding dictionaries and tracking trial sponsors' requirements.
- Participate in and contribute to clinical data management initiatives.
- RN, M.D., M.Sc., or Ph.D. in Pharmacology or a related field, or equivalent education.
- Two to three years' experience in clinical trial data management, including medical coding and laboratory data management.
- Broad knowledge of clinical trial safety data coding and management.
- Ability to effectively manage medical information and communicate effectively with personnel at all levels.
