Data Management

BEENA VADAPALLI

732-***-****(M)

732-***-****(H)

*******@*******.***

SUMMARY:

Master’s in Computer Science and Bachelor’s in Computer Science

15+ years of Clinical Data Management experience

* ***** of Lead DM experience

10 years of CRO management experience

15 years of experience managing third party vendors

11 years of CRF development/design experience

11 years of experience performing UAT testing

11 years of experience performing SAE, Lab and third party reconciliation

11 years of experience writing and testing edit checks

Experience writing Data Management Plans, Transfer Specifications, eCRF Guidelines, etc.

11 years of EDC experience (Rave, OC/RDC and InForm)

3 years of OC/RDC experience

2 years of iReview and 5 years of JReview experience

11/2 years of experience in Medical Device (IUD)

PROFESSIONAL EXPERIENCE:

BAYER HEALTHCARE PHARMACEUTICALS (Formerly Berlex Pharmaceuticals)

June 2009 to Present

Study/Project Data Manager Consultant (June 2009 to Present)

Lead and manage multiple projects simultaneously serving as a liaison between clinical, statistical, monitoring and CRO data management teams for all studies

Create and implement several project plans and successfully conduct all the activities from database startup, conduct and database lock in order to meeting strict timelines for submission to CSR

Apply Global Clinical Data Management best practice for all assigned studies

Manage all study data management teams efficiently and consistently

Provide valuable input in developing and/or reviewing protocols, protocol deviation documents, Timing Domain, CDISC aligned standards and data transfer specifications

Specify and/or develop study specific data components (Study Metadata), work with EDC developer in the design of eCRF’s and Database structures

Develop and implement study specific data consistency checks (edit checks) in the data validation document

Contribute to the DM part of the study package test

Perform consistency checks for external data (internal consistency and consistency with other data)

Request and coordinate the SAS-programming of edit checks and derivations, also the programming and execution of programs from original data to analysis database

Prepare Database Closure Plans and present to Study Teams

Conduct database-closure activities

Coordinate DM activities among study teams in preparation for global medical surveillance

Work in SAS Environment creating metadata, code list updates, coding software

Perform UAT for EDC studies, update eCRF guidelines and Data Management Plan

Work closely with the EDC programmer and the Clinical Data Center programmers

Monitors at site to resolve data issues

Perform SAE reconciliation

Address and resolve lab discrepancies from the third party vendors

Environment: Rave, Tosca, Macumba, SAS viewer, MS-Excel, Themis and MS-Word

Sr. Clinical Data Manager Consultant (April 2007 to May 2009)

Participated in the database lock of Women’s Healthcare projects

Managed CROs

Presented at Investigator meetings, study team kick-off meetings and weekly meeting with CROs

Performed validation checks, tested the screens, and managed study through closeout

Performed lab reconciliation, and SAE reconciliation, coding for con-meds and adverse events

Contributed to the development of protocols, CRFs and data handling guidelines for the Phase II/III/IV studies

Worked with clinical data entry associates to ensure the data was entered in the database

Used Integrated Review, J-Review, and TOSCA (SAS) to review listings for the study

Managed all medical review queries and assisted the Global Pharmacovigelance Department

Participated in study team meetings, and coordinated with in-house CRAs and CROs in the process of database lock of study

Identified errors and inconsistencies in CRF data and ensured the resolution of data issues

Updated the validation checks

Deployed Diary pages in Access database and trained the data entry team

Worked on Medical Device, reconcile device ID, and manage the measurements were entered.

Worked in Medidata Rave (EDC) studies

Environment: Clintrial 4.3, MS-Excel, Integrated Review, J-Review, Tosca, Rave and Epower 6.1

DOV PHARMACEUTICALS

October 2006 to March 2007

Clinical Data Manager Consultant

Worked on EDC (Etrials) based studies

Involved in closing out of Phase I and Phase II studies for Chronic Back Pain

Used Etrials to review the eCRF’s data, involved in posting the queries to the sites, site had to update and close the queries

Managed the CRO (Contract Research Organization) within United States and international CRO’s

Used SAS viewer to pull the listing and worked on the listing, depending on the review used to send out the queries to the site

Normally the review was done on Cohorts, once the Cohort was done, used to tell the CRA’s from CRO’s company to go for a monitoring visit and later freeze the database

Involved in requesting the source documents and performed monitoring when the CRO was laid off

Used MS-Access to deploy a form for protocol deviation

Followed all eCRF development SOPs and EDC standards

Provided feedback on standards performance once deployed

Ensured that all eCRF testing was completed and documented

Provided input if eCRFs were audited

Maintained assigned eCRFs including making updates to deployed eCRFs and ensured that all updates were fully tested before deployment

Worked closely with the Director, CRA’s and the Data Management Team

Involved in SAE and lab reconciliation

Involved in conducting meeting with the sites which were outsourced to the other countries

Lab reconciliation was done with the third party database MAYO Labs, Inc. with the etrial database; SAE reconciliation was done from etrial database with the CATO database

Environment: Etrials from Quick Study (EDC), SAS, Access and Excel

BERLEX PHARMACEUTICALS INC.

November 2005 to September 2006

Clinical Data Manager Consultant

Worked in Open-label Phase II and III Trials of Leukine(Active Crohn's Disease)

Worked in Clintrial, involved in reviewing, resolving, sending out the queries to the sites and updating the database, Validating in CT Manage and viewing the Validation log to make sure all the queries were closed

Involved in scanning the DCF's and indexing them in Epower

Used Epower, to pull the CRF pages and DCF's for daily activities

Involved in other project activities

Used Integrated Review to pull the SQL's, looked for all the lab values and also in tracing out the missing pages

Environment: Clintrial 4.3, MS-Excel, Integrated Review and Epower 6.1

ORGANON PHARMACEUTICAL INC.

July 2005 to October 2005

Clinical Data Analyst Consultant

Worked on Phase III study

Performed all the activities for database lock

Posses’ good knowledge of Oracle Clinical discrepancy management

Involved in doing data cleaning, query handling, interacting with clinical team, CRAs and Biometrics

Updated the medical review queries in the Documentum

Edited and verified the validation checks

Reviewed the queries, resolving and updating the queries

Performed manual checks to ensure the Cardiovascular, Breast and Gync Adjudications, also involved in doing error rate calculation

Developed study level eCRFs including programming the edits, and derivations

Used CRF Web Viewer (EDC) to pull the scanned CRF page

Environment: Oracle Clinical 4.5, Documentum 1.0, MS-Excel-2000 and MS-word -2000

ABBOTT LABORATORIES

May 2004 to June 2005

Data Manager Consultant

Worked in two different Ankylosing Spondylitis and Psoriasis studies

Two Ankylosing Spondylitis protocols’ belong to Phase III

Psoriasis Phase II and Phase III

Responsible for executing data management process required to lock study database

Involved in SAE reconciliation using SOAR database; involved in reviewing the queries and resolving and updating the database

Involved in generating track status for the discrepancies and the CRF’s

Coordinated project personnel involved in all data management activities/objectives

Responsible for CRF process flow and query resolution and acted as liaison with study team members/functional groups on all levels, domestic and international, on technical requirements for database development and quality Reviewed CRFs to ensure completeness and clinical accuracy of information

Involved in specifying appropriate validation specifications for the assigned project/study

Involved in performing discrepancy management activities as needed, based on output generated from the batch validation specifications

Environment: Oracle Clinical 4.0.8, SAS, SOAR, Lotus, MS-Access 97, MS-Excel 97, MS-Word 97 and Unix

MERCK & CO, INC.

October 2003 to April 2004

Associate Data Specialist/Clinical Data Coordinator Consultant

Assigned to work on clinical trial projects in Type II Diabetes & Obesity as a team member with minimal supervision

Worked on Phase III protocol for Type II Diabetes Mellitus with placebo insulin and Merck compound

Assisted in freezing the database

Worked in Phase II protocol for Type II Diabetes Mellitus with placebo, glipizide and Merck compound

Solved critical problems for both clinical and computer issues

Reviewed clinical trial data from case report forms (CRFs) and database listings from the client’s proprietary database management systems for accuracy against the Data Review Plan, issued queries to the site and proof returned and updated responses

Played a key role in ensuring quality, consistency, and integrity of clinical trials databases

Executed database management programs and performed data validation reviews

Resolved data discrepancies and annotate data listings accordingly

Communicated those discrepancies to sites or data entry staff as appropriate

Maintained accurate study documentation

Contribute to data management process improvements. Follow accepted

Environment: CTS (Clinical Trial System) 4.3, Clinical Data Management Tool, Adhoc Queries, Oracle 9.0i, MS-Excel 2000 and MS-Access 2000

INGENIX PHARMACEUTICAL SERVICES, NJ

August 1999 to September 2003

Clinical Data Coordinator (August 2002 to September 2003)

Worked as a Clinical Data Coordinator in a 24-week, Multicenter, Randomized, Double-Blind, Placebo controlled evaluation of the safety and efficacy of Donepezil Hydrochloride in Patients with Severe Alzheimer’s Disease followed by a 12 week open-label extension period; it was an on-going study

Involved in creating subjects, investigators list & linking the particular study sites

Used to review and clean data in clinical databases-including performing medical coding, SAE and lab reconciliation, and discrepancy management-for purposes of achieving a clean, reportable database within prescribed/agreed timelines

Used to effectively communicate work status to project/study team and to management, including timely rising of alerts to any issues that could potentially impact timeliness, quality or data integrity

Worked as a QC Auditor when the list of randomly selected patients enrolled in the study

Once done with the QC Auditing, if the errors were genuine, used to update the database

Used to compare the dataset SAS annotation with the original CRF's; if at all any discrepancy was found would generate a query to the investigator's site and also involved in updating the DCF (data clarification form)

Worked in Split Screen and solved many problems which were caused in the Epower Application while transferring data to the Oracle Clinical

Epower acted as a RDC (Remote Data Capture)

Used to retrieve the scanned electronic CRF document for verification

Involved in page tracking in MS-Excel 2000

Possessed experience in indexing the CRF's, by using E.Power 6.1, involved in Automatic and Manual Indexing

Environment: SAS, Oracle Clinical, E.Power 6.1,MS-Excel 2000 and MS-Word 2000

Clinical Data Associate (August 1999 to July 2002)

Worked in Rescue Study, a prospective, open-label, randomized, parallel-group investigation to efficacy to safety of enoxaparin versus unfractionated heparin in subjects who present to the emergency department with acute coronary syndrome

Worked in split screen for this study

Epower provided electronic CRF's; once the data was captured, it would be reconciled on the split screen. There no

Retrieved the missing CRF's from the Epower

Involved in creating subjects, investigators list & linking to the study sites

Worked on Tenofovir (A Canadian Study), Ortho-McNeil, Purdue, J & J & Mitsubishi studies

Environment: SAS, Oracle Clinical 4.0.3/3.0.2, E.Power 6.1,MS-Excel 2000 and MS-Word 2000

EDUCATION:

Master’s in Computer Science (Osmania University)

Bachelor’s in Computer Science (Osmania University)

COMPUTER SKILLS:

Software: Medidata Rave, Globedoc, TOSCA (Bayer home built application), Etrials (EDC), Oracle Clinical 4.5.0/4.0.8/4.0.6/4.0.3/3.0.2, Documentum, CRF WebViewer(EDC), CTS (Clintrial System), Data Management Tool, SAS, ClinTrial 4.3/4.0, EPower 6.1(Electronic Data Capture tool), MS-Excel 2000, MS-Word 2000, Java 2, JavaScript 1.2, EJB, Servlets, Applets, HTML 3.2, Corba, Swing, JDBC, AWT, Beans, RMI, JSDK2.0, JWS 2.0, Web logic 5.1, Visual Basic 6.0/5.0, Dream Weaver 4.0, Front Page 98,Visual Interdev 1.0, PERL, SQL, PL/SQL, Oracle 9.0i/8.x/7.x, MS-SQL Server 6.5/7.0, MS-Access 97/2000, ASP 3.0 using VBScript, PASCAL, C, C++

O/S: Windows 95/98/2000/ME/NT and UNIX

Hardware: IBM Compatible PC-AT 386-486, Intel Pentium, Dell Pentium

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