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The Senior Clinical Database Programmer is responsible for the programming of high-quality clinical databases and for the provision of expertise in clinical database technology. Responsible for supporting assigned segments of client’s portfolio. Accountabilities to include the design, development, and maintenance of clinical databases, ensuring the integrity of clinical data, application of standards supporting consistency in asset/submission data. The Clinical Senior Database Programmer mentors’ junior staff in database technologies and client’s standard database conventions. Serves as a subject matter expert on the Database build design of eCRFs and clinical databases across one or more therapeutic areas.
Job Responsibility:
Works closely with department roles and cross-functional study team members to create data capture solutions that support the quality and timely delivery of data required per standard and study specific data review plans
Complies with applicable SOPs and work practices
Serves as subject matter expert in one or more technologies
Leads and contributes to cross-functional technical initiatives in collaboration with clients Digital and other teams
Supports knowledge development of data capture tools and methods that support the accuracy and integrity of study data
Requirements:
Bachelor's degree in Life Science, Computer Science or equivalent
Minimum of 5 years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions
Technical skills and experience using relational databases (e.g. Oracle InForm, Rave EDC System, Oracle DMW, MS SQL Server or MS Access)
Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills
Rave Custom Function Programming skills are mandatory
Strong communication (written and oral), decision-making, influencing, negotiation, and project management skills
Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word, Excel, etc.)
Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g. data review, study reports, regulatory submissions, safety updates, etc.)
Understanding regulatory requirements and relevant data standards