CDM

Manju-Uma Pandey-Vimal

** **** ******, *** (H): 978-***-****

Lowell, MA 02155 Tel (C): 978-***-****

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

EDUCATION

Arts & commerce college, Devi Ahilya University, Indore, M.P., India, Ph.D. in Theory of Color Vision as depicted in Vedic literature…, 2001- 06

M.M.M. Regional Engineering College, Gorakhpur University, India, P.G.D.C.A. in Computer Science (Programming), 1995-96

Gorakhpur University, Gorakhpur, India, Master. 1991-93

Gorakhpur University, Gorakhpur, India, B.Sc. in Chemistry, Zoology, and Botany, 1988-91

SUMMARY OF EXPERIENCE

Clinical Data Manager II, PAREXEL International, Lowell, MA, USA, April 2008-June 2009.

Primary Clinical Data Analyst, PAREXEL, Lowell, MA July 2009-May 2012.

Lead Clinical Data Manager, VERISTAT, Holliston, MA May 2012-Present.

Lead Clinical Data Manager at VERISTAT and working on various phases, such as phase I to III trials from Start-up through database lock on both Paper (Clintrial) and EDC (InForm) studies. I perform all aspects of study management as applicable to Data Management.

Clinical Data Manager at PAREXEL International for 4 years and worked on various phase I and III trials from Start-up through database lock on both Paper (Oracle Clinical and Clintrial) and EDC (InForm and Medidata Rave) studies, performing all aspects of study management as applicable to Data Management.

Therapeutic experience includes endocrinology (Diabetes), Acute hereditary angioedema, Oncology, Vaccine, Ecstasy (MDMA), and Addiction (Drug) studies.

I have device experience for oncology.

Previous experience includes being a Research Associate at Vision Research Institute on an Ecstasy (MDMA) project and Circadian system project, and as a Research Specialist at the McLean Hospital (affiliated with Mass General Hospital).

EXPERIENCE

VERISTAT, Inc. Holliston, Massachusetts

Lead Clinical Data Analyst May 2012 to Present

The duties of the position included the following:

Project Lead on a Phase I and a Phase III Clintrial Studies, and a Phase II InForm Study.

Integrate, review and reconcile data received from external vendors with clinical database and ensure readiness for analysis.

Review of Sponsor generated listings to ensure commonality of databases.

Review outputs of edit check and assist in revision of a DVS including addition of new edit checks and Protocol Violation listings.

Perform study start-up activities including form design, preparation of edit checks, database testing (User Acceptance Testing).

Create Data Validation plan and Data Cleaning Specifications including Lab and SAE reconciliation plan.

Draft and finalize CRF Completion Instructions, Data Handling Guidelines.

Write offline-listing specifications for data review, protocol violations and lab data reconciliation guidelines.

Review and reconcile electronic data from vendors (Central Laboratory data) and Serious Adverse Events (SAE) to ensure the accuracy and correctness between the CRF data and E-data, and issue queries as applicable.

Execute training sessions for junior team members in Lowell, MA; RTP, India and South Africa offices on data cleaning activities including data review and query integration.

Facilitate cross-functional team meetings both internally (study team members, coders, biostatisticians and other functional groups on technical requirements for database development and data transfer, and CRF/queries process flow) and externally (sponsor, e-data vendors).

Prepare weekly study metrics and ad hoc reports to monitor study team productivity and progress; update Sponsor, Clinical team and Data management teams

Perform functional QC and provide feedback on Raw-data transfer output and export datasets.

Perform Database Quality Assessment (Critical Items audit and Blended audit) of study data at Database lock.

Create and Maintain Central Files for all study related procedures, guidelines and correspondences in accordance with SOPs.

PAREXEL International Lowell, Massachusetts

Primary Clinical Data Analyst April 2008 to May 2012

(Clinical Data Manager prior to Company wide reorganization)

The duties of the position included the following:

Integration of Investigator and Sponsor initiated query responses in clinical database (Paper- Oracle Clinical and Clintrial and EDC – InForm and Medidata Rave)

Integrated, review and reconcile data received from external vendors with clinical database and ensure readiness for analysis.

Performed raw data review and validation on discrepant data using the Data Validation Specifications.

Reviewed of Sponsor generated listings to ensure commonality of databases.

Reviewed output of edit check and assist in revision of a DVS including addition of new edit checks and Protocol Violation listings.

Reviewed CRFs, and data listing to identify discrepancies in the clinical trial data as specified in DVS.

Generated weekly metrics report and provide Sponsor with feedback on the Raw Data transfer.

Created SQL scripts to obtain daily data review and query metrics.

Project Primary on a Phase II EDC InForm study and a Phase III Oracle Clinical and Phase IV Clintrial Studies.

Performed study start-up activities including form design, preparation of edit checks, database testing (User Acceptance Testing).

Created Data Validation plan and Data Cleaning Specifications including Lab and SAE reconciliation plan.

Draft and finalize CRF Completion Instructions, Data Handling Guidelines.

Reviewed and provided feedback of study contract; recognize out of scope activities and communicate to PM / DM Lead.

Write offline-listing specifications for data review, protocol violations and lab data reconciliation guidelines.

Review and reconcile electronic data from vendors (Central Laboratory data) and Serious Adverse Events (SAE) to ensure the accuracy and correctness between the CRF data and E-data, and issue queries as applicable.

Executed training sessions for junior team members in Lowell, MA; RTP, India and South Africa offices on data cleaning activities including data review and query integration.

Facilitated cross-functional team meetings both internally (study team members, coders, biostatisticians and other functional groups on technical requirements for database development and data transfer, and CRF/queries process flow) and externally (sponsor, e-data vendors).

Prepared weekly study metrics and ad hoc reports to monitor study team productivity and progress; update Sponsor, Clinical team and Data management teams across Europe, Latin America, Russia, India, Canada, South Africa and North Americas on the project status.

Performed functional QC and provide feedback on Raw-data transfer output and export datasets.

Managed and coordinate team activities worldwide (India, South Africa) from start-up through maintenance and lock of the study.

Performed Database Quality Assessment (Critical Items audit and Blended audit) of study data at Database lock.

Created and Maintain Central Files for all study related procedures, guidelines and correspondences in accordance with SOPs.

Research Associate, Vision Research Institute, Acton, MA, July 2005- March 2008

Analyzing anatomical and functional brain imaging data related to Ecstasy (MDMA) project, circadian system (suprachiasmatic nucleus: human master clock), vision and attention system and perform statistical analysis for Dr. Ram Vimal using BrainVoyager, STATVIEW, and MATLAB software. I am learning STATVIEW and MATLAB software.

Research Specialist, McLean Hospital, Behavioral Psychopharmacology Research Laboratories (BPRL), Belmont, MA, USA, April 2005- June 2005

Analyzed anatomical and functional brain imaging data related to reward system (faces and spinners) and perform statistical analysis using BrainVoyager software.

Research Consultant, McLean Hospital, Behavioral Psychopharmacology Research Laboratories (BPRL), Belmont, MA, USA, February 2005- March 2005

Analyzed anatomical and functional brain imaging data and perform statistical analysis using BrainVoyager software.

Research Assistant, McLean Hospital, Brain Imaging Center, Belmont, MA, USA, October 2002-January 2005

Assisted fMRI drug-abuse and visual psychophysical research.

Performed data analysis of Ecstasy (MDMA) users and control subjects using BrainVoyager.

Analyzed anatomical and functional brain imaging data and perform statistical analysis.

Assisted with grant proposals, and screen subjects using vision, alcohol, drug, and pregnancy tests.

Assisted in Internal Review Board (IRB) approval for a research project. This included IRB application, human consent form, research protocol, telephone screening, advertisement for human subjects, and authorization regarding use of protected health information (PHI) and health insurance portability and accountability act of 1996 (HIPPA) authorization and privacy language in the consent form. Consistency with FDA (Food and Drug administration) was observed.

Assisted in manuscript preparation (please see below).

Lab. Instructor (Faculty member), Indira Gandhi National Open University, Lucknow, U.P., India, January 1999- February 2001

Helped students in CIC, DCA, BCA, MCA Labs (Part time).

Computer Programmer, Prosixsoftron, Lucknow, U. P., India, April, 1998-February 2001

Handled projects of various business streams in C++ including following projects: Inventory system, Payroll system, Life insurance, and Text editor (Part time).

Computer Programmer, Century Corporation, Lucknow, U. P., India, March 1997-March 1998

Worked on Inventory system, and Pay-slip generation system.

Areas of expertise:

Hardware: Compaq, Intel Pentium, V40 system

Languages: C, C++, VC++, JAVA, SDK, VB, ASP, PASCAL, and COBOL

Software: DOS, Unix, ASP 3.0, Oracle, Windows, NT, Servlets, Sybase, SDK, Java Script, SQL Server, VC++, VB (includes operating systems, databases, utilities, tools, and LANs).

Language Skills:

English: fluent

Hindi: fluent

Academic Appointment(s):

Indira Gandhi National Open University, Lucknow, U.P., India, Lab. Instructor (Faculty member), January 1999- February 2001

Ph.D. Thesis:

Chaturvedi, M. “THEORY OF COLOR VISION AS DEPICTED IN VEDIC LITERATURE with reference to Dristi Shaktipat” Unpublished Ph.D., Devi Ahilya University, Indore, M.P., India. (2006)

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