Medical Policy Manager jobs in Fairfield, CA

The Role

The Clinical Data Manager is responsible the clinical trial and database management to oversee and execute clinical data management activities including but not limited to case report form (CRF) design, database setup, review, and validation, data validation, and database lock. In addition, the Clinical Data Manager processes clinical data, including but not limited to the receipt, entry, verification, and generation of data queries to resolve errors and omissions during data entry. 

A Few Key Responsibilities

• The Clinical Data Manager will be responsible for performing Data Management activities that support ExThera Medical commercial and development projects worldwide
• Be able to perform a thoroughly detailed review of eCRF data requirements
• Support the development of data edit check specifications and data listings
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards
• Able to resolve EDC system issues with team members
• Able to review and provide feedback to the clinical team on other study documents e.g., Clinical Monitoring plans, Statistical analysis plans and vendor specifications
• May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
• Perform reconciliation of header data from external data sources against the clinical database
• Be able to maintain study workbooks and data management files
• Identify and resolve data flow process issues in collaboration with the project team
• Contributes to initiatives within the organization, with groups engaged in developing good regulatory practice
• Interface with other members of the regulatory, clinical, medical affairs and R & D teams to provide support and expertise as needed
• Assist with the training of new employees and/or contractors

• BA/BS, preferably in the scientific/healthcare field, or an equivalent combination of education and work experience
• 2 years of experience in data management 
• Medical device and/or in vitro diagnostic experience highly preferred
• Experience with REDCap Cloud, REDCap academic version, or other electronic data capture software
• Ability to manage multiple and/complex studies
• Facility with electronic data capture software
• Experience and understanding of the Oncology or therapeutic area requiring intensive care, and with Phase III pivotal studies are preferred.
• Knowledge of applicable regulatory rules and guidelines, such as ICH GCP
• Ability to work in a regulated environment in compliance to ISO 13485:2016, US CFR, MDD/MDR, CMDR, MDSAP and all other applicable regulations
• Excellent interpersonal and communication skills
• Ability to work with clinical site personnel to resolve data queries
• Ability to work in a team environment and manage competing timelines
• Highly self-motivated and capable of independent work
• Proficient with Microsoft Office Suite