CLINICAL DATA MANAGER
Duties: The Clinical Data Manager (CDM) is responsible for data quality and documentation for assigned clinical trials conducted within the Center for Cellular Immunotherapies to ensure that the clinical data collection is accurate and all protocol requirements are captured. The Clinical Data Manager is responsible for providing clinical data management support for assigned Center for Cellular Immunotherapies (CCI)-Initiated protocols, including all tasks associated with study data management necessary for DSMB meetings/reports, IND Annual Reports, monthly reports, and interim data reporting/database locks, as well as ad hoc queries.
To be successful in this role the Clinical Data Manager will need to maneuver within a matrixed environment and be comfortable working with various electronic database systems. The Clinical Data Manager is also expected to have familiarity and experience with clinical trial protocols and related regulatory requirements for therapeutic clinical trials.
In addition, the Clinical Data Manager (CDM) will:
* Independently create CRFs (Case Report Forms) in an electronic database systems to collect required data from all clinical trials. The Clinical Data Managers ensures data collection is accurate, capturing all activities required by the protocol including, but not limited to all data groups such as: enrollment information, clinical labs/procedures, demographics, infusion information, response data, etc. The CDM must be able to understand the needs of complex, high-risk, gene and immunotherapy clinical research protocols, and accurately build case report forms that capture required research information to ensure primary and secondary endpoints are captured.
* Continually evaluate the CRFs for required modification due to the dynamic nature of this research. Amend CRFs due to protocol amendments/changes in study endpoints.
* Assist in the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures.
* Develop and conduct Investigator/Study Team training on the Clinical Database, CRFs, and data entry requirements.
* Provide input into study and project level data analysis plans.
* Participate in the preparation and presentation of study data/reports.
* Facilitate data cleaning activities including data review and query generation for assigned protocols
* Produce and provide metrics on data entry/processing to the Project Manager.
* Assist in implementing process changes and system improvements.
* Coordinate the archiving of study data and study related documents for assigned protocols.
* Interact with the Sponsor/Sponsor Program Managers, Project Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure required data is captured.
The minimum of a Bachelor's degree and 3-5 years experience, preferably in clinical data management/clinical data analysis, or an equivalent combination of education and experience required.
Solid clinical research background; Understanding of and experience in all aspects of data cleaning procedures.
Knowledge of electronic data capture systems required.
Experience with computer programs such as MS Word, Excel, PowerPoint, etc.
Good understanding of and/or experience with descriptive data analysis methods, the drug development process and associated federal regulations and guidelines (i.e. FDA, CFR, ICH, GCP).
Reference Number: 40-29889
Salary Grade: 027
Employment Type: Exempt
Org: CI-Center for Cellular Immunotherapy
Job Family: I-Technical/Professional Research