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When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were 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 clients 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 clients 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:
Bachelors 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.
Required Experience:
Senior IC
Full Time