Job Posting for Clinical Data Manager at ExThera Medical
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
What You Bring
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
Relocation benefits are not offered for this role. The expected salary range for this position based on the primary location of Martinez, Ca is $140,295 and $153,856. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Salary.com Estimation for Clinical Data Manager in Martinez, CA
$126,583 to $157,585
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