Clinical Data Manager (Contract)

You will make an impact:

• Experienced Clinical Data Manager with expertise in the review and reporting of clinical data throughout the entire data lifecycle. Proven track record of developing comprehensive study documentation, designing, implementing, and managing data deliverables from start-up to closeout in adherence to industry standards and regulatory requirements. Skilled in fostering collaboration among clinical operations, biostatistics, and programming teams to integrate data management activities and enhance operational efficiency. Committed to continuous improvement by staying knowledgeable of emerging technologies and industry trends to implement best practices for effective and efficient data management.

Your day to day:

• 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

Qualifications:

• 5+ years’ experience in Clinical Data Management preferred
• Bachelor’s degree in a health-related field or equivalent experience preferred
• CCDM Certification preferred
• 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
• Experience with Cloud SaaS platforms (preferred)
• Experience with data reporting tools such as Qlik, JReview, Spotfire preferred
• Experience with RBQM methodology preferred
• Exposure to CDISC guidelines and standards