What are the responsibilities and job description for the Senior Clinical Research Data Manager position at Children's National Hospital?
The Sr Clinical Data Manager will help oversee the clinical database and clinical data management aspects of the Biostatistical and Study Methodology Division and provide support for the implementation of project specific database design, creation and testing. Train staff on implementation of clinical data management SOPs and policies. Choose and implement appropriate methods to address clinical research questions by preparing tables, graphs, and results and written interpretation. Work closely with all Coordinating Center staff and study team leadership to accomplish these goals.
Qualifications : Minimum Education
Bachelor's Degree Applicable degree such as Epidemiology, Biostatistics, Information Systems or a related field. (Required)
Master's Degree Applicable degree such as Epidemiology, Biostatistics, Information Systems or a related field (Preferred)
Minimum Work Experience
3 years Demonstrated of data management in FDA regulated clinical studies in human subjects. (Required)
5 years Demonstrated of data management in FDA regulated clinical studies in human subjects. (Preferred)
Required Skills / Knowledge
Knowledge of REDCap, OpenClinica, SAS or other database systems
Demonstrated excellent written, verbal, interpersonal and communication skills
Good multi-tasking and organizational skills.
Understanding of statistical reporting and basic analysis functions
Functional Accountabilities
Database Management
- Work directly with the client on the creation of clinical study databases.
- Prepare Clinical Data Management Plans for complex studies
- Oversee the development and implantation of data validation with checks and query programs.
- Prepare, update and review clinical data management documentation.
- Oversee project specific clinical database design, creation and testing.
- Oversee the testing of clinical data management system edit / validation checks and discrepancy management activities being done by the Clinical Data Manager or Clinical Data Coordinators
- Provide support and act as the Senior Clinical Data management point person to the Sponsor, CROs, vendors, clinical sites, and scorers
- Develop presentations and present at Investigator meetings
- Train, track, and manage users (Sponsors, Sites, Investigators and other study personnel) on the CDMS
- Manage delivery of projects through full clinical data management process life-cycle,
- Create, track, and manage clinical data management timelines, proposals, and budgets.
Standard Operating Procedures
Clinical Data Analysis and Reporting
Teamwork / Communication
Performance Improvement / Problem-solving
Cost Management / Financial Responsibility
Safety
