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.

- Robust 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.

📌 Clinical Data Associate (Pune)
🏢 TalentXpert
📍 Pune