Summary:

The Clinical Database Programmer is responsible for the programming of high-quality clinical databases. Responsible for supporting assigned segments of the 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.

Responsibilities:

• 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.

• Learn client’s database technologies.

• Develops knowledge of data capture tools and methods that support the accuracy and integrity of study data.

Qualifications:

• Bachelor's degree in Life Science, Computer Science or equivalent.

• Minimum of 1+ years of relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.

• Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.

• Technical skills and experience using relational databases (e.g. Oracle InForm, Oracle DMW, MS SQL Server or MS Access).

• 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; CDISC knowledge and experience are preferable.