Clinical Data Associate

TalentXpert; Pune District; On-site; INR 800,000 - 1,400,000; Full time

Job summary

TalentXpert in India is seeking a Clinical Data Manager with at least 3 years of experience in data management for CRO/pharma/device sectors. You will review trial data, run ancillary programs, and maintain data quality in accordance with SOPs and DMPs.

The role involves data reconciliation across clinical, safety, lab, and vendor data, developing data models and eCRFs, and creating validation checks. Strong communication, organizational skills, and knowledge of CDISC standards are essential.

Qualifications

• 3+ years of clinical data management experience in CRO, pharmaceutical, biotech, or device company.
• In-depth understanding of database structures and database programming.
• Knowledge of CDISC SDTM/CDASH standards.
• Familiarity with ICH, GCP, and GCDMP (SCDM).
• Strong analytical and problem-solving skills.
• Excellent organizational, planning, and time management abilities.
• Proficiency in MS Windows, Word, Excel, PowerPoint, and email applications.
• Good verbal and written communication and interpersonal skills.
• Self-motivated and highly organized.

Responsibilities

• Review clinical trial data per Data Management Plans and SOPs to identify erroneous, missing, incomplete, or implausible data.
• Run ancillary programs (diagnostics, listings, reconciliation listings) to support data review.
• Generate, resolve and track queries to address problematic data and apply corrections to the database.
• Reconcile the clinical and safety databases.
• Reconcile central laboratory and/or third-party vendor data.
• Perform aggregate review of clinical data by patient/site/project to identify data trends or inconsistencies that require investigation.
• Assist in the development of the clinical data model and/or database design (eCRF).
• Assist in the development and testing of data management system checks (diagnostics) and listings/tools used for data review and discrepancy management.
• Other duties & responsibilities as required.

Skills

Database programming

CDISC SDTM/CDASH standards

Analytical thinking

Problem solving

Communication skills

Interpersonal skills

Organizational skills

Self-motivation

Tools

MS Excel

MS Word

PowerPoint

Email applications

Job description

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.