Clinical Data Associate

Role & responsibilities

• Review clinical trial data in accordance with Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data.
• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data.
• Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database.
• Perform reconciliation of the clinical and safety databases.
• Perform reconciliation of central laboratory and / or third-party vendor data (laboratory data, SAE data etc.).
• Perform aggregate review of clinical data by patient, site and / or project to identify data trends (patient safety, compliance, etc.) and / or data inconsistencies that require further investigation.
• Assist in the development of the clinical data model and/or database design (eCRF) according to specifications.
• Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
• Other duties & responsibilities as required.

Education and Years of Experience:

• A minimum of 3 years of clinical data management related experience in either a CRO, pharmaceutical, biotech, or device company.

Other Skills and Abilities:

• In-depth understanding of database structures and database programming.
• In depth knowledge of CDISC SDTM/CDASH standards.
• In-depth knowledge of clinical trial processes and experience in ICH, GCP, and GCDMP (SCDM).
• Strong analytical, problem solving, and technical skills in database programming.
• Strong organizational, planning, and time management skills with the ability to multitask under tight deadlines while providing attention to detail.
• Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications.
• Knowledge of at least one computer programming language is an asset.
• Must have strong communication (both verbal and written) and interpersonal skills.
• Must be highly organized and self-motivated.