KEY TASKS & RESPONSIBILITIES
- Primary representative for eClinical Solutions/Sponsor data management interaction, ensure eClinical Solutions data management process is followed and deliverables meet quality and timelines within approved Scope
- Senior technical resource providing Data Management services for project requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, Query Management, Vendor Reconciliation
- Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central 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 Data Central and analytics modules
- Function as senior DM consultant to sponsor providing guidance on data management best practices as applied to sponsor and protocol specific situation
- Perform data trending review via reporting and elluminate analytics to identify risks and develop mitigation and data cleaning strategies
- Monitor and interpret key performance indicators (KPIs), dashboards, and reports to provide actionable recommendations to client
- Delegate and prioritize tasks, provide project oversight and guidance to study data management team mentoring junior level staff and peers on all associated tasks within a study helping to grow individual capabilities
- Support business development by participating in proposal defenses
- Maintain project documentation related to assigned tasks
- Other duties as assigned
CANDIDATE S PROFILE
Education & Experience
- 8-10 years of experience in Clinical Data Management
- Bachelor s degree in health-related field or equivalent experience
Professional Skills
- Strong project management experience and project team leadership skills including work planning and work delegation
- Strong consulting and client relationship management skills
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent verbal and written communication skills
- Excellent team player
- Excellent knowledge of English
Technical Skills
- 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
- Experience with data reporting tools such as Qlik, JReview, Spotfire
- Experience with RBQM methodology preferred
