Key tasks & Responsibilities

• Define project specifications for Data Management services, including Protocol Conversion,

Database Build, CRF Design and Data Review and Data Reconciliation tools.

• Understand external data collection, its integration into the clinical trial, and the management and

reconciliation processes required to ensure its accuracy and relevance.

• Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and

ensure high-quality, timely deliverables.

• Perform holistic data review and trending analysis via reporting and elluminate® analytics to

proactively identify issue, risks and develop mitigation strategies.

• Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to

enhance the efficiency and quality of trial data.

• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial

Operational Analytics (CTOA), and reports to provide actionable recommendations to study

lead(s)/project manager.

• Perform Query Management





• Define specifications and collaborate with technical team on configuration of centralized data

management platform, elluminate® Data Central for data cleaning strategy and oversight activities.

• Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and

update throughout trial lifecycle.

• Review and ensure the quality control of team-developed deliverables, covering eCRFs, study

documents, program/report specifications, outputs, and elluminate® Data Central with analytics

modules. Actively evaluate and contribute to enhance processes to increase efficiency and

effectiveness.

• Collaborate and work as a team to ensure the deliverables are completed on time with high quality.

• Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and

procedures.

• Other duties as assigned.

Candidat's profile

Education & Experience

• 5+ y

📌 Clinical Data Manager (Bengaluru)
🏢 Trigent Software
📍 Bengaluru