Tarrytown, United States
almost 2 years ago
Position Title: Clinical Data Manager II the data manager oversee the studies to drive innovative database building, data collection, tracking and review solutions from complex, diverse sources to ensure timely delivery of high quality data in a regulated and changing global clinical trial environment. Duties & Responsibilities:
- Leads the development and implementation of innovative strategies and technologies for database design.
- Collaborate with Clinical Affairs team to understand changes and help develop data and technology strategies to support those business strategies.
- Manage vendor (when applicable) to ensure data quality and timely delivery
- Participates in the review of Clinical research documents (e.g. Protocols, Reports and Statistical analysis).
- Develops Data Management Plan (DMP) throughout lifecycle.
- Develop Case Report Form (CRF), electronic and/or paper.
- Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, and query logic and data validations.
- Lead EDC database (DB) specification process.
- Reconcile electronic data.
- Develop test scripts and execution logs for User Acceptance Testing (UAT).
- Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
- Author or review CRF completion guidelines.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock- included but not limited to: data reconciliation.
- Assist in defining and/or create data listings for data management review purpose, summary table validation and data specifications for data management audit.
- Coordinate the archiving of study databases and related documents.
- Perform close-out audit, as specified, for closing of study trial in EDC or other clinical data management DBs.
- Coordinate and communicate with DB vendors on consistent basis to address Clinical team requests, project plans, and/or eCRF development activities where applicable.
- Participate in conference calls and/or meetings with study team.
Qualifications & Skills:
- Bachelors degree in a science related field.
- At least five (5) years data management and/or related work experience in a medical device, Diagnostics or pharmaceutical industry/company.
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC and CTMS.
- Proficient knowledge of Medidata RAVE, experience with RaveX is a plus
- Strong understanding of application of clinical data coding classification systems, e.g., MedDRA, WHO-Drug.
- Strong interpersonal, organizational, and communication skills.
- Excellent attention to detail and problem solving skills.
- Ability to work effectively work in a team setting.