Our client is hiring a Manager, Clinical Data Management to be located in the East Bay of CA!
Oakland-Fremont-Pleasanton Metro Area, CA
- Responsible for all aspects of clinical data management associated with database development, UAT and validation processes, data transfers, data cleaning and quality review processes for assigned projects with minimal supervision.
- Coordinate and complete in-house data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting. Ensures clinical trial data collected meet the highest standards of data integrity while meeting timelines and budgets.
- Process clinical data including receipt, entry, verification and filing of information
- Track the flow of work forms including in-house data flow, electronic forms transfer and progress reports
- Perform Adverse Event reconciliation
- Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials and after study closeout
- Ensure the delivery of clinical trial databases of the highest quality by establishing procedures for ongoing and final data review
- Ensure that CDM study files are organized and accessible during study conduct
- Ensure that CDM activities for clinical trials and regulatory submission projects are completed on time
QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):
Required a Bachelor s Degree in the Life Sciences field; MS preferred
6-7 years of experience in clinical data management, including experience with FDA regulated trials and requirements
In-depth knowledge of clinical trials process and regulatory requirements, CDM processes and procedures within the medical device industry
Adept at the mechanics of conducting all phases of clinical trial data management within EDC
databases, and skilled in validation and data review in EDC databases
Excellent presentation, organizational and communication skills, both verbal and written
Team player and effective independent contributor who can adapt to multiple priorities in a fluid environment
Proficient in computer technology/applications (documents, spreadsheets, databases