KEY TASKS & RESPONSIBILITIES
- Define project specifications for Data Management services, including Protocol Conversion, Database Build, CRF Design and Data Review and Data Reconciliation tools
- Understand external data collection, its integration into the clinical trial, and the management and reconciliation processes required to ensure its accuracy and relevance
- Execute data cleaning strategies to accelerate the time to achieve subject data cleanliness and ensure high-quality, timely deliverables
- Perform holistic data review and trending analysis via reporting and elluminate analytics to proactively identify issue, risks and develop mitigation strategies
- Utilize artificial intelligence (AI) and machine learning (ML) for anomaly and outlier detection to enhance the efficiency and quality of trial data
- Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to study lead(s)/project manager
- Perform Query Management
- Define specifications and collaborate with technical team on configuration of centralized data management platform, elluminate Data Central for data cleaning strategy and oversight activities
- Prepare and maintain data management documentation (e.g., DMP, CCGs, Help Text, DVS) and update throughout trial lifecycle
- Review and ensure the quality control of team-developed deliverables, covering eCRFs, study documents, program/report specifications, outputs, and elluminate Data Central with analytics modules. Actively evaluate and contribute to enhance processes to increase efficiency and effectiveness
- Collaborate and work as a team to ensure the deliverables are completed on time with high quality
- Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures
- Other duties as assigned
CANDIDATE S PROFILE
Education & Experience
- 5+ years experience in Clinical Data Management preferred
- Bachelor s degree in a health-related field or equivalent experience preferred
- CCDM Certification preferred
Professional Skills
- 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
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 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
