Oversee clinical data management including system development, maintenance and final data assessment activities for ongoing and planned clinical trials. Manage external vendors who provide clinical databases development and data management functions. Work in conjunction with the Study Project Team, Clinical Operations, Safety Team, Regulatory Team and Biostatistics Team.
location: Warren, New Jersey
job type: Temporary
salary: $55 - 60 per hour
work hours: 9 to 5
- Responsible for the development of the data management plan for each clinical trial
- Reviews work orders for database development and data management externalvendors
- Oversee the development and management of clinical databases for clinical trials including eCRF design, and edit rules/checks
- Monitor data for completeness and accuracy; query management and trending.
- Oversee the development of interim analysis reports for data monitoring committee
- Coordinate and communicate with data management vendors on consistent basis to address clinical, safety, study and regulatory team requests on project plans, eCRF development activities, data management and data cleaning activities
- Participates in preparation and preparation of data outputs including tables, listings and graphs, when applicable
- Participate in conference calls and/or vendor meetings
- Oversee the adherence to timelines for database development, eCRF development, data cleaning, interim analysis reports and final CSR reports.
- Establish the data management strategy and plan for ongoing and planned clinical trials
- Oversee and coordinate the activities of external vendors for database development and data management activities. Includes providing daily oversight of vendors to ensure compliance to timelines for data management
and the timely identification and resolution to any barriers that may impact data quality, integrity, or study timelines
- Monitor timeliness and quality of data collection and coordinate activities of data analysis including query management.
- Prepare data outputs in the form of summaries, listings, graphs, etc. to support interim analysis, final analysis and strategic decisions as needed.
- Assist in the data management closeout and final data analysis for the final clinical study report
- Reports to project team the status of the database development, clinical data collection, data cleaning and data management timelines and milestones
Education: Minimum of a Bachelor's Degree, preferably in Life Science, Math, Computer Science/Programming, or commensurate experience in Data Management.
Experience: At least 5 years data management experience in multiple therapeutic areas and multiple study phases
- In depth knowledge of clinical trial process and data management, eCRF development, database management, data cleaning, and data analysis
- Detailed knowledge of Oracle Clinical software and other related Data Management software
- Working knowledge of SAS and data requirements for statistical analysis
- Established history of working with and overseeing multiple vendors to support data management activities and needs
- Strong technical skills with ability to perform data analysis and develop data reports, metrics, etc.
- Excellent organizational and communication skills and ability to work independently within a matrix environment
skills: Clinical Data Management
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.