Clinical Data Manager

1w1 week ago

eClinical Solutions

Bengaluru, IN · Full-time · INR 2,000,000 – INR 3,500,000

About this role

eClinical Solutions helps life sciences organizations accelerate clinical development with expert data services and the elluminate Clinical Data Cloud. The Clinical Data Manager supports the study team by developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance, data cleaning, and closeout activities for clinical trial databases. As platform expert, the role leverages cutting-edge tools for continuous data insights and timely high-quality results.

Day-to-day involves defining project specifications for Data Management services like Protocol Conversion, Database Build, CRF Design, Data Review, and Reconciliation tools. Execute data cleaning strategies, perform holistic data review with trending analysis via elluminate analytics, and utilize AI and ML for anomaly detection. Monitor KPIs, metrics, dashboards, and CTOA to provide actionable recommendations.

The CDM collaborates with study leads, project managers, and technical teams to configure elluminate Data Central for data oversight. Perform Query Management, prepare documentation like DMP and CCGs, and ensure quality control of deliverables including eCRFs and reports. Work as a team to meet timelines with high quality while complying with industry standards.

Gain recognition as platform expert adapting clinical data management to evolving processes integrating clinical data science. Proactively identify issues, risks, and develop mitigation strategies for smarter decisions. Contribute to enhancing processes for efficiency in digital trials.

Requirements

5+ years’ experience in Clinical Data Management preferred
Bachelor’s degree in a health-related field or equivalent experience preferred
CCDM Certification preferred
Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems
Strong analytical and strategic thinking skills
Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Excellent collaborative skills
Demonstrated command of the English language with proficiency in both verbal and written communication

Responsibilities

Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools
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 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 key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations
Perform Query Management
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, and elluminate® Data Central