Hi Hope you are doing well
I am Steven, working as a recruiter with Infotree Service Inc. I am currently working on “*Sr. Clinical Database Analyst - EDC*” position with our reputed client. I will appreciate your response at the earliest, as the managers tend to move fast! *NOTE :** SEND RESUMES WITH THESE DETAILS , Profiles with all mandatory details would be processed with TOP Priority* *Name (First & Last)* *Contact No.* *Email ID * *Current Location* *Willing to Relocate if need* *Work Visa Status*, *Expiry Date* *Availability * How soon can you join?* *Reason for change* *Are you fine with drug and background check?* *Skype ID* *Last 4 Digit SSN No.* *DOB(Day, Month)* *Higher Education, Year of Completion * *Job Title* *Sr. Clinical Database Analyst - EDC* *Project Location* *Woodcliff Lake, NJ** 07677* *Duration* *12+ months /Contract* *Skills* *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 Data Management* department within *Oncology Product Creation Unit* 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. • Guide junior developers/designers for most efficient and feasible method in designing eCRFs and building edit checks. • 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, data transmission, and testing • Ensure all programming activities and processes performed are conducted according to the 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 InForm and IRT environments for clinical trials • 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 *Thanks & Regards,* *Steven* - Technical Recruiter *Phone *(Direct): 734-888-8174 *Email:* ste...@infotreeservice.com <st...@infotreeservice.com> | *Website:* www.infotreeservice.com *LinkedIn:* https://www.linkedin.com/pub/steven-fernandez/104/956/240 *Hangout:* steven.usrecruiter | *Yahoo:* steven.usrecruiter *Mailing Address:* 215 Ann Arbor Rd. 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