Description
Sr. Clinical Database Analyst (EDC)* Design, build, test, deploy, and manage assigned Oncology EDC trials using Oracle's EDC product, InForm.
* Design eCRF screens and build rules for data validation checks using Central Designer in InForm.
* Provide advanced level programming and technical support, end users support and trouble shooting for Data Management department within Oncology Product Creation Unit with quality and efficiency.
* Guide junior developers/designers for most efficient and feasible method in designing eCRF's and edit checks.
* Develop standard, Ad-hoc reports, and listings within InForm to support Clinical Data Management, Clinical Operations for data cleaning, data reviewing and trial monitoring functions.
* Collaborate with external vendors/PDMs to develop and maintain external data transfer specification, data transmission, testing, and data loading.
* Ensure all programming activities are performed following the departmental standards and guidelines.
* Perform user management, coordinate User Acceptance Testing, and production roll out activities for individual trials.
* Perform post production changes.
* Liaise with vendors to resolve and follow-up outstanding / escalated technical issues.
* Manage the assigned projects independently within established timelines.
Qualifications:
* Strong programming skills required with Oracle's EDC system, InForm, Central Designer, COGNOS, with proficiency in Central Designer
tool, COGNOS, C#, XML, SQL, PL/SQL; Good knowledge of ORACLE database structure
* At least 7 years of experience in programming with at least 5 years with systems and programming in clinical trial area in
developing/managing clinical database design and related technical solution.
* Understanding of standards specific to clinical trials in the Oncology area, Good knowledge of Coding process, central labs, local
labs, CDISC, CDASH, SDTM, MedDRA, and WHODRUG.
* Knowledge of IRT system, ClinTrial, and SAS is a plus.
* Knowledge of clinical data management process, randomization, clinical data entry, coding process, external vendor data processing is required.
* Good understanding of clinical data handling process in Oncology area is needed.
To find out more about Real Staffing please visit www.realstaffing.com