Note: The job is a remote job and is open to candidates in USA. eClinical Solutions provides clinical data services and the elluminate Clinical Data Cloud to help life sciences organizations accelerate clinical development. The Clinical Data Manager supports sponsor and study data management activities, oversees clinical data deliverables throughout the data lifecycle, performs quality control and data review, and drives process improvements using analytics and reporting.
Responsibilities
- Acts as support for primary DM representative for eClinical Solutions and sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved scope
- Provides study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management
- Define specifications and collaborate with technical team on configuration of elluminate for data cleaning strategy and oversight activities
- Perform Quality Control on deliverables developed by team members including study documents, program and report specifications, deliverables and elluminate modules
- Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks, and develop mitigation strategies
- Monitor and interpret key performance indicators (KPIs), metrics, dashboards, and reports for process and efficiency improvement
- Other duties as assigned
Skills
- Strong project management experience and project team leadership skills including work planning, work delegation and solving complex problems
- 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
- 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
- 5+ years' experience in Clinical Data Management preferred
- Bachelor's degree in a health-related field or equivalent experience preferred
- CCDM Certification preferred
- Experience with Cloud SaaS platforms (preferred)
- Experience with data reporting tools such as Qlik, JReview, Spotfire preferred
- Experience with RBQM methodology preferred
Company Overview
Company H1B Sponsorship