Eclinicalsolutions
Clinical Data Manager
Bangalore, Karnataka. Posted 2 months ago
The role
The Clinical Data Manager supports the study team by developing study documentation and designing database specifications. This role oversees validation, maintenance, data cleaning, and closeout activities for clinical trial databases.
What you will do
- Define project specifications for Data Management services
- Understand external data collection and integration into clinical trials
- Execute data cleaning strategies
- Perform holistic data review and trending analysis via reporting and analytics
- Utilize artificial intelligence and machine learning for anomaly and outlier detection
- Monitor and interpret key performance indicators, metrics, dashboards, and reports
- Perform Query Management
- Collaborate with technical team on configuration of centralized data management platform
- Prepare and maintain data management documentation
- Review and ensure quality control of team-developed deliverables
Required qualifications
- Strong project management experience and project team leadership skills
- 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
- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
- Proficient with EDC and Clinical Data Management Systems
- Exposure to CDISC guidelines and standards
Nice to have
- 5+ years’ experience in Clinical Data Management
- Bachelor’s degree in a health-related field or equivalent experience
- CCDM Certification
- Experience with Cloud SaaS platforms
- Experience with data reporting tools such as Qlik, JReview, Spotfire
- Experience with RBQM methodology
About the company
eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. It is a people first organization with an inclusive culture.