SUMMARY

• A variety of CTMS, Data Management, Technical and Clinical Trial experience gives me the ability to fully understand business process of pharmaceutical Companies.
• Experience on applications used in Pharmaceutical Industry Mainly IMPACT, Oracle Clinical, ClinTrial, OnPoint etc.
• Consultant with 15 + years of experience with expertise in CTMS, Clinical Trials, Business objects BOXI R2/ 3.1, 6.5, 6, 5.X (Webi/Deski)PL/SQL, Client Server Internet and Intranet technologies.
• Experienced in site selection, data cleaning, writing queries, regulatory document review and data verifications between various data bases like INMPACT, IVRS, Oracle Clinical, ClinTrial etc.
• Have knowledge of FDA regulations, Guidelines a d Standard Operating Procedures.
• Experienced with Software Development Life Cycle (SDLC), including requirement analysis, design, development, testing and implementation.
• Well acquainted with Word Processors, Spreadsheets, and Office Communication Tools.
• Experienced in writing Oracle PL/SQL Stored Procedures, Functions, Packages, Triggers and Performance Tuning.
• Excellent analytical Skills, problem solving, communication and interpersonal skills, with ability to interact with individuals at all levels.
• Outstanding work ethic, time management skills and a consistent team player.
• Performed Data management and developed PL/SQL packages and BO Reports for DM, Tracking and CRF Workflow .application.
• Successfully completed ‘GCP’ and ‘Drug Development Process’ courses from Temple University.

TECHNICAL SKILLS

• CTMS
• Oracle Clinical
• IMPACT
• Business Objects BOXI R2/ 3.1, 6.5, 6, 5.X (Webi/Deski)
• PL/SQL
• SDLC
• Data Management
• MS Office
• CRF Workflow
• OLAP (TM1)
• REMS
• Cognos
• PFC Power Builder Web App
• Designing GUI

PROFESSIONAL EXPERIENCE

Confidential  

Sr. Business Analyst/Product Owner

Responsibilities:

• Using a wide range of techniques to capture business requirements.
• Working with business owners to develop solutions.
• Documenting, testing and implementing software updates.
• Identifying client business requirements.
• Meeting with project teams to review deliverables and deadlines.
• Producing test plans and scenarios on behalf of the business.
• Writing UAT test scripts.
• Making sure that all tests are conducted and documented according the standards.
• Gap analysis.
• Detailed evaluation of CTMS application OnPoint.

Confidential

Functional Lead/Architect

Risk Evaluation and Mitigation Strategy (REMS) for following reports:

• Patient Exposure Data.
• FDA Audit Support.
• Dispense Summary.
• Patient Enrollment.
• Metrics for ICD - 9 Codes.
• Support to REMS, CTMS, Business Objects & Cognos
• Clinical Studies Tracking using CTMS database.
• Product wise and Study wise analysis.
• Pharmacovigilance Master File for EMA reporting needs.
• Analysis of Departmental Expenses.
• Cash forecast & Budgets for studies.
• Generating reports and presentations for top management.
• Reports for FDA Audits.
• Applications Support.
• Collecting Requirements from Users.
• Expense Reports Using Cognos 8.
• Variance of expenses (Actual Vs Budget).

Confidential

Group Leader

• Developed full Tracking System.
• Study Analysis.
• Enrollment.
• Developed reports with Alerter and Sort & Filters.
• Multi-level break reports.
• Cross Tab Reports.
• Wrote pl/sql function and created object using created function.
• Reports with Sections.
• Break Calculations for multiple levels.
• Created reports with multiple queries.
• Created multi tab reports.
• Created Multi table reports for receivable summary.
• Created report with Alerter which keeps Track of all outstanding payments.

Confidential

CTMS Expert (IMPACT)/Application Manager/In House CRA/ Assistant Study Manager

• Study Set up in CTMS (IMPACT) for all the Studies (Study, Country and Site Level).
• Setup of visit design in IMPACT for all the studies.
• Closing Study in IMPACT after CSR report is approved.
• Create Sites Through application ‘Profile’.
• Created Reports for FDA Audits using IMPACT Database.
• Compare data IMPACT V/S IVR.
• Support study managers for IMPACT tracking system.
• Performed investigator evaluation based on historical data review and on input from CRAs.
• Tracking all studies and prepare presentation for management regarding progress of studies.
• Co-Ordination with CRO and sites for any data issues.
• SAE reconciliation
• Creation of patient profiles using I-Review.
• Tracking IRB Approvals, form 1572, CVs, Financial Disclosures etc.
• Help in maintaining TMF for studies.
• PSA calculation for the Prostate Cancer studies.
• Cash Forecast and Budget for studies.
• Work closely with CTC to ensure timely investigational site payments.
• Report of sites, which have received shipment of drugs but no recruitment.
• Percentage wise report of patients enrolled and patients completed.
• Generate listings for issues and corrective actions for all the studies.
• Percentage wise analysis of Progression of disease, Withdrawals & Deaths.
• Report for the sites set up in Oracle Clinical.
• Ad hoc reports for the Oracle Clinical regarding received DCMs, DCI, Question etc.
• Create sites, Investigators, Patient positions in OC.
• Mapped OC fields with CTI application tables for Page Tracking.
• Support to Users for Resolving Discrepancies.
• Generating MIS reports using Business Objects and PL/SQL.
• Graphical representation of data using Business Objects.
• Developed Drill down Business Object reports.
• Report writing using I-Review.
• Checking data consistency using I-Review and Oracle (ClinTrial database and IMPACT database)
• Ad hoc reports as per requirements using I-review.
• Created Patient Profile using I-Review.
• QA of CRF Which were scanned and submitted to FDA.

Confidential

Data Analyst/Online Result System

• GUI: Power Builder 6.5 / 7
• Database: Sybase 11.9
• Operating System: Windows NT
• Confidential . is a leading laboratory specializing in drug testing products and services. As a analyst I handled the following areas of the project:
• Customer Setup - This module handles customer login & access control based on user profile.
• This was done using PFC Power Builder Web Application: Developed & implemented the frame work to send customer related data from PB data windows to the web pages through Developed new reports giving advanced sales details for selected customers.
• Gathering & Understanding requirements.
• Preparing functional Specification documents and getting approvals from client.
• Designing GUI screens.