*Only C2C*

Hi

Hope you are doing well

I am Smith, 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*

*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. Suite 304 Plymouth, MI 48170





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