Clinical Data Manager

About the role

The Clinical Data Manager (CDM) supports study teams by developing study documentation, designing database specifications, and overseeing validation, data cleaning, and closeout activities for clinical trial databases.

Key responsibilities

• Define project specifications for Data Management services, including protocol conversion, database build, CRF design, and data review tools.
• Execute data cleaning strategies to accelerate subject data cleanliness and ensure high‑quality, timely deliverables.
• Perform holistic data review and trending analysis via reporting and elluminate® analytics to proactively identify issues, risks and develop mitigation strategies.
• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance trial data efficiency and quality.
• Monitor and interpret KPIs, metrics, dashboards, Clinical Trial Operational Analytics and reports to provide actionable recommendations.
• Perform query management and oversee data reconciliation processes.
• Define specifications and collaborate with technical teams on configuration of elluminate® Data Central for data cleaning oversight.
• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) throughout the trial lifecycle.
• Review and ensure quality control of team‑developed deliverables, including eCRFs, study documents, program/report specifications, outputs, and elluminate® analytics modules.

Required profile

• 5+ years of experience in Clinical Data Management (preferred).
• Bachelor’s degree in a health‑related field or equivalent experience (preferred).
• CCDM Certification (preferred).

Required skills

• Strong project management and team leadership abilities.
• Analytical and strategic thinking with attention to detail.
• Excellent collaboration and communication skills in English.

Technical skills

• Proficiency in Microsoft Office applications, especially MS Project and MS Excel.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology.
• Experience with EDC and Clinical Data Management Systems.
• Familiarity with cloud SaaS platforms.
• Experience with data reporting tools such as Qlik, JReview, and Spotfire.
• Exposure to RBQM methodology and CDISC standards.
• Use of AI and ML for data anomaly detection.