Principal Clinical Data Manager

Responsibilities

• Primary representative for eClinical Solutions and sponsor data management interaction
• Ensure data management processes are followed and deliverables meet quality and timelines
• Function as DM subject matter expert providing guidance on best practices, technology, and solutions
• Provide study requirements including Protocol Conversion, Database Build, CRF design, Data Entry, Data Verification, Data Review, and Query Management
• Define specifications and collaborate with technical teams on elluminate® configuration
• Perform Quality Control on study documents, program specifications, and elluminate® modules
• Perform quality oversight and data trending via reporting and analytics to identify risks
• Collaborate with technical and engineering teams on tech-enabled solutions for efficiency
• Collaborate with functional managers and training teams to deliver training

Requirements

• Bachelor's degree or higher in relevant health science or scientific/technical discipline
• 10+ years of experience in Pharmaceutical/Biotechnology industry
• Experience in Clinical Data Management or equivalent consulting role
• Strong project management and team leadership skills
• Strong consulting and client relationship management skills
• Proficiency in Microsoft Office, specifically MS Project and MS Excel
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology
• Proficiency with EDC and Clinical Data Management Systems
• English language proficiency (verbal and written)

Preferred Qualifications

• CCDM Certification
• Experience with agile and six sigma methodologies
• Experience with Cloud SaaS platforms
• Experience with data reporting tools such as Qlik, JReview, or Spotfire
• Experience with RBQM methodology
• Exposure to CDISC guidelines and standards

About the Company

eClinical Solutions helps life sciences organizations accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud. We are committed to driving innovation in clinical trials through a better approach to data management and analytics.