Clinical Data Manager

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

eClinical Solutions is committed to driving innovation in clinical trials through a better approach to data management and data analytics. We use the eClinical Solutions technology platform, elluminate, throughout the data management process to accelerate timelines for our clients and automate manual processes. We believe in a more agile approach to data management using our core technology elluminate – enabling our life sciences clients to proactively manage their clinical programs and make decisions.

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.

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.

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 issues, 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

Take the first step towards your dream career. Here is what we are looking for in this role.

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), and data reporting tools such as Qlik, JReview, Spotfire preferred
• Experience with RBQM methodology preferred
• Exposure to CDISC guidelines and standards