We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Data Associate I in Rockville, MD This position is vital for ensuring the accuracy and integrity of clinical data collected, particularly in relation to biospecimen management and associated metadata. The successful candidate will play a key role in collaborating with internal teams and external partners, including CROs, central laboratories, and bioanalytical laboratories.

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.

Required Skills and Qualifications:

• 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.