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Senior Clinical Database Analyst
Ref No.: 18-25854
Location: Woodcliff Lake, New Jersey
Sr. Clinical Database Analyst - EDC
• Provide programming and technical support related to clinical trials, end users support, and trouble shooting using different modules of Oracle's EDC product, InForm for Integrated Oncology Data Services (IODS) department within Oncology Business group with quality and efficiency.
• Design eCRF screens and develop programs for data validation checks for clinical trials using Central Designer in InForm for Data Management and data entry.
• Perform formal QC process for all the design and development activities.
• Develop standard and Ad-hoc reports and listings to support Clinical Data Management, Clinical Operations for data cleaning, data reviewing, and trial monitoring functions.
• Help in preparing external data specification for different external data transmission, and testing & loading .
• Ensure all programming activities and processes performed are conducted according to the standard EDC library, standard operating procedures, programming standards, and good programming practices.
• Prepare trial deployment packages for UAT and production environment
• Maintain users using UMT tool for the assigned studies related to InForm and IRT.
• Provide end user support.
• Analyze Data Management & Clinical need and come up with solution methods.

Qualifications:
• Strong programming skills required with Oracle's EDC system, InForm, Central Designer, COGNOS Reporting database, with proficiency in Central Designer tool, COGNOS, .NET technologies, XML, SQL, PL/SQL; Good knowledge of ORACLE database structure
• At least 7 years of experience in programming with at least 3 years with systems and programming in clinical trials area within pharmaceutical/biotechnology companies in developing/managing clinical database design and related technical solution.
• Understanding of standards specific to clinical trials mainly in Oncology area. Good knowledge of Coding process, central labs, local labs, CDISC, CDASH, SDTM, MedDRA, WHO Drug.
• Knowledge of IRT, Central Coding, IReview / JReview, Clintrial, SAS is a plus
• Knowledge of clinical data management process, randomization, clinical data entry, coding process, external vendor data processing,
• Good understanding of clinical data handling process in Oncology area
• Strong analytical and problem solving skills, handling multiple projects simultaneously.
• Experience with end users support, Team player, Good organizational and time management skills, project management skills
• Capable to work independently, communicating technical concepts, strong communication skills
• Knowledge of Regulatory Guidelines in terms computer system validation , 21 CFR part 11,GCP, computer system validation