At PRA Health Sciences, providing innovative solutions for our clients is what we do. Side-by-side with our clients, we strive to move drug discovery forward, helping them to develop life-saving and life-improving drugs. With our unique blend of expertise, we provide comprehensive clinical development services across all phases. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
Post: Clinical Database Developer
Responsibilities:
- Develop the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries.
- Create, test and maintain trial specific plausibility and consistency checks.
- Provide data transfer specifications for third party data.
- Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes.
- Develop database specifications and provide support for outsourced trials.
- Create, file and maintain appropriate trial documentation.
- Program procedures of low to medium complexity from documented trial specific requirements, within the clinical database system using SQL or PL/SQL.
- Maintain and update procedures as required for protocol amendments or required post production changes.
- Execution of trial design reports based on trial metadata.
- Understanding of corporate Clinical Data Standards.
Education Qualifications:
University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics, or equivalent degree
Experience/Professional:
At least 6 months to 2 years experience in clinical database programming, setup of clinical databases and CRF design, and procedure /validation programming, as part of the setup of clinical databases, gained in the pharmaceutical industry, CRO or Life science related industry as well as the following
Requirement:
· Basic knowledge of SQL or PL/SQL
· OC/RDC experience preferred
· Basic understanding of clinical data management systems and/or relational databases as applied to clinical trials
·Attention to detail, quality, time management and customer focus
· Ability to translate technical concepts for non-technical users in the areas of clinical database design and procedure development
· Strong verbal and written communication skills to work with our global partners and customers.
· Basic understanding of Drug Development Process, ICH-GCP and Health Authority guidelines and regulations.
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