Clinical Data Manager, Sr

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