Clinical Data Manager
Seeking an experienced Clinical Data Manager to fill an opening with top diagnostics company based in the Marlborough, MA area. This is a temp to hire opportunity with room for growth. Drug and Background check required.
Responsible for managing all aspects of clinical data management activities for clinical programs which could span across start-up, ongoing, and database lock activities, including projects that have been contracted to CROs as well as internal paper or EDC projects.
- Ensure data accuracy and integrity in preparation for statistical analysis, ensuring the quality of data produced either at company or by CROs
- May review clinical database-related output and deliverables produced by CROs on an ongoing basis to ensure database quality and integrity for CRO and company Data Management
- Develop and standardize case report form design
- Ensure that all clinical data received and processed are completed and accurate for all parameters required by the study protocol per company Data Management SOPs
- Understand and maintain documentation that SOPs are followed for company Data Management
- Compare and reconcile adverse event data captured in Drug Safety with adverse event data captured on the case report form (as applicable)
- Review and evaluate any data received from sources other than case report forms (e.g., central laboratory data) and ensure readiness for analysis. Code concomitant medications, and other data as needed.
- Design and produce, in conjunction with Clinical and Biostatistics, data listings for review of the accuracy, completeness and consistency of clinical trial data
- Specify database edit checks and follow data discrepancy resolution procedures
- Monitor timelines and ensure that deadlines are met. Participate in development and maintenance of Standard Operation Procedure (SOPs)
- May oversee CROs in their delivery of data management milestones where appropriate; liaise with third party vendors and EDC vendors in a project manager capacity
- Bachelor of Science degree preferred, preferably in health related field and/or computer; or some college and strong exprerience
- 3- 6 years’ experience in clinical data management in the pharmaceutical/biotechnology/diagnostic industry
- Experience in all phases of data management for clinical trials is preferred
- Diagnostic experience a big plus
- EDC experience preferred
- Experience working with OpenClinica a plus
- Demonstrated ability to follow Clinical Data Management SOPs
- Coding experience with WHO Drug, ICD-9, MedDRA desirable
- Knowledge of GCP, regulatory and ICH Guidelines as applicable to data management
- Excellent written, verbal and organizational skills; work effectively as a team player