Resume

Sign in

Oracle Clinical Programmer

Location:
Mercer Island, Washington, United States
Posted:
May 26, 2010

Contact this candidate

PRITI YADAV

763.***.******** Dahlia Circle  Dayton, NJ 08810  kh9yta@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

Sr level Oracle Clinical Programmer with outstanding abilities and experience in data analysis and managing clinical data management systems. Talented problem solver with background in troubleshooting problem issues to enhance company bottom line. Expert with proven track record in the following broad-based areas:

OC Global Library

OC Database Design

Program Edit Checks

OC RDC

Report Listings

21 CRF Part 11

OC TMS

Standard Operating Procedures

CTMS

 Extensive experience in working with clinical data management systems used in large clinical studies and projects. Strong knowledge of clinical trial management systems (CTMS).

 Excellent experience in Clinical Trials Data Management using Oracle Clinical 4.0.3 and 4.5.3. Data Plan, Data Design, GLIB, Data Definition, Validation Procedures, Derivation Procedures, TMS.

 Proven ability to establish and maintain excellent working relationships with co-workers, department staff, and other representatives.

TECHNICAL EXPERTISE

Trial Management: Oracle Clinical v 4.5.3 (CDMS), Oracle Clinical RDC, Clindex (CTMS), OC TMS, Siebel CTMS, CRF Design Review

Applications: Oracle Reports, Toad, SQL Developer, Microsoft Products, Visio

Languages: SQL, PL/SQL, XML, HTML, Javascript, C, UNIX, Java

EXPERIENCE

MANNKIND CORP, NJ Jan 2010 – May 2010

Contractor (Oracle Clinical Programmer)

Responsible for the designing studies in Oracle Clinical RDC which includes designing Case Report Forms, validation procedures, derivation procedures, OC TMS, reports, etc.

 Designed 2 studies in OC RDC.

 Set standards for defining Questions in OC Glib.

 Built standard reports for the department that could be used as validation documents for study design.

 Set up the peer review process for study validation.

MEDTRONIC, Minneapolis, MN May 2000 – Jul 2009

Senior / Principal Oracle Clinical Programmer – Neuromodulation

Administered the Clinical Data Management system. Analyzed more than 14 clinical trials using Oracle Clinical system (CDMS) which included designing case report form layouts in Oracle Clinical, writing 100’s of validation procedures (edit checks), and report listings. Responsible for managing the clinical trial management system (CTMS) across 3 business units.

 Built and designed clinical studies for 14 clinical trials. Responsible for maintenance of OC Global Library. Expert knowledge of OC backend tables.

 Built and designed 2 clinical studies in Oracle Clinical RDC mode (version 4.5.1, and version 4.5.3)

 Provided recommendation for Business Objects to be used by the Business Unit by evaluating multiple reporting tools.

 Recommended Seibel Clinical application as the most viable option by analyzing CTMS requirements across multiple business units.

 Authored multiple Standard Operating Procedures (SOP) and work instructions for CTMS system, resulting in uniform practices across business units.

 Ensured successful adoption of Clindex CTMS (Clinical Trial Management System) across business units by developing support documents, Standard Operating Procedures, work instructions, and training materials.

 Ensured compliance with monitoring of Case Report Forms by implementing monitoring metrics for clinical trials.

 Piloted corporate metrics to evaluate compliance at sites across clinical trials, determining success attributes of well-run trials.

 Implemented data entry standards across business units for the Clindex CTMS application eliminating duplication of data in the master Sites and Personnel tables.

 Implemented standard processes across business units by holding focus group meetings for the Clindex CTMS application.

 Facilitated smooth integration between Seibel Clinical and Oracle Clinical databases (CTMS & CDMS) by consulting as Subject Matter Expert for interfacing between the two systems.

WHITTMAN-HART, Minneapolis, MN Jan 1999 – Apr 2000

Senior Developer

 Created new product offering by developing conversion system to transfer data between multiple systems.

 Programmed reports to client specifications in clinical domain, leading to eventual hire by Medtronic for exceptional contribution.

DELHI UNIVERSITY, India 1996 – 1997

Lecturer

 Developed, taught grad level courses and consulted with University Database Center.

TATA CONSULTANCY SERVICES, India 1995 – 1996

Developer – Banking Applications and Packaged Software Systems Developer

 Developed systems to customer specifications for banking applications resulting in packaged software systems.

EDUCATION

Master of Science in Computer Applications, MADRAS UNIVERSITY, India

Bachelor of Science in Math, honors, DELHI UNIVERSITY, India

COMMUNITY INVOLVEMENT

Volunteer, AMERICAN HEART ASSOCIATION – Minneapolis Chapter

Coordinated activities to raise awareness and funds for the cause.



Contact this candidate