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Clinical Data Specialist
1 week ago
Advanced Clinical is seeking a skilled professional to join our team as a Clinical Data Associate I. This position is vital for ensuring the accuracy and integrity of clinical data collected, particularly in relation to biospecimen management and associated metadata.
Key Responsibilities:- Assist with the flow of bioanalytical data collected in clinical trials.
- Oversee the lifecycle of biospecimens collected during clinical trials and ensure proper management of associated metadata.
- Create and review specification documents for accurate data collection.
- Perform data review and programming tasks to maintain and clean clinical data related to biospecimen collection.
- Collaborate with internal clinical management, programming, and data management teams, as well as external CROs, central laboratories, and bioanalytical laboratories.
- Create and review data entry specifications for case report forms and other relevant documents to ensure the proper collection of biospecimens.
- Review metadata across multiple datasets, ensuring consistency (e.g., subject identifiers, protocol visit names, sample collection dates/times), and manage data cleaning processes if discrepancies arise.
- Ensure the accuracy and completeness of data related to biological sample collection and measurement during clinical trials.
- Bachelor's degree in Life Sciences or related field.
- At least 3 years of clinical research experience.
- Familiarity with SDTM guidelines.
- Experience working with LIMS databases and biosample tracking tools.
- Proven ability to work collaboratively in cross-functional teams.
- Strong organizational skills and the ability to manage multiple, complex projects.
- Excellent verbal and written communication skills.
- Solid knowledge of bioanalytical regulations.