Join our Oncology R&D team as a Clinical Database Developer I, where you will create the Clinical Database Development (CDD) deliverables on assigned clinical studies. You will be responsible for the quality of CDD deliverables following standards, Standard Operating Procedures (SOPs) and Guidelines. You will also maintain Business Continuity for CDD processes and standards including integrity of the clinical database for the relevant studies.
Accountabilities:
As a Clinical Database Developer, you will be responsible for the timely and quality creation of electronic Case Report Forms (eCRFs), data entry screens, and the design, build and testing of clinical databases. You will also program field derivations, edit checks, consistency checks, validations, procedures and rules. Additionally, you will develop study reporting and visualization environment, create study level documentation for all databases used in data management, and ensure timely and quality system testing and Quality Control (QC) of specified deliverables.
Essential Skills/Experience:
- Bachelors degree, preferably in computing or scientific discipline - Database development experience in the pharmaceutical industry working with clinical trial data - Experience in Study Build activities (Study Design & Validation Rule development) in Medidata Rave - Basic knowledge of Postproduction changes in Medidata Rave - Practical experience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL - Excellent written and verbal communication skills - Ability to work in a global team environment - Good analytical skills and high attention to detail - Experience in other EDC tools(Inform, Veeva etc) are added advantages
- Knowledge of clinical and pharmaceutical drug development process and Clinical trials - Understanding of data standards (CDISC) and practices - Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences - Experience in Medidata Rave Custom Functions - Experience with programming languages SAS, Python, R, PLSQL or Java are added advantage