Senior Clinical Database Programmer, FSP (South Africa)

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Summary:

The Senior Clinical Database Programmer is responsible for the programming of high-quality clinical database 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 Analyst mentors junior staff in database technologies and client’s standard database conventions. Serves as a subject matter expert on the design of eCRFs and clinical databases across one or more therapeutic areas.

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.

• 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.

Qualifications:

• 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, Oracle DMW, MS SQL Server or MS Access).

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

• 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.

Originally posted on Himalayas