THE ROLE:

Coordinates data management activities in support of clinical and/or non-clinical research studies including document management, query management, database setup and testing, and quality control of the data and project deliverables.

WHAT YOU’LL DO:

• Track and maintain audit-ready clinical study documentation within the electronic and/or hard copy Trial Master Files for multiple projects
• Perform query management including data listing review, query creation and resolution, ensuring data is complete, consistent and accurate
• Perform advanced aspects of data cleaning process, including reconciliation of Serious Adverse Events and third-party vendor data, or other cleaning tasks as necessary
• Assist Clinical Data Manager(s) in prioritizing project workloads, as needed
• May participate in database setup including data entry screen and validation check user acceptance testing, updates to eCRF Completion Guidelines or other CDM study documentation, with oversight from Clinical Data Manager
• Serve as an interim resource for study issues pertaining to data management in the absence of the Clinical Data Manager
• Mentor and train Clinical Data Associates in query management and other data cleaning activities
• Maintain quality control of the data, project deliverables and closeouts
• Track and maintain audit-ready clinical study documentation within the electronic Trial Master Files for multiple projects, with Clinical Data Manager oversight
• Participate in internal and external team meetings, as necessary
• Adhere to all aspects of Ora’s quality system.
• Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora’s data integrity & business ethics and regulatory requirements.Clear and sustained demonstration of Ora’s values
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• prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors.

• Responsibilities may differ from the above based on the specific needs of the business.

Experience needed for the Role:

• Bachelor’s degree, preferably in applied or life science, with 1-3 years of experience in data management of clinical trials or equivalent education and work experience