Clinical Data Manager or Study Data Manager or Senior Clinical D

LEA SOYFER 25 Corey Road Flanders, NJ 07836 (862) 219-5648

EDUCATION Physician's Degree, Surger y Autonomous University of Gua dalajara, Mexico Medical School B.A., Biology Queens College of the City University of New York PROFESSIONAL EXPERIENCE 03/2008-Present

Clinical Data Manager RPS, Inc.

Performed clinical trial Data Management activities for Phases I to IV; executed UAT for several trials; participated in database designs and forms development; created/validated edit checks via DDS system; oversaw data entry function; generated and resolved queries via Rave and Inform systems; tracked queries via a Query Log Manual; reviewed data listings; QCed of data fo r several trials; generated IReview listings as needed for data review; executed SAE reconciliation for several trials; coded medical terms via AES system; lock ed and participated in database locks for several trials which were locked on ti me and with favorable results. 03/2007-10/2007

Clinical Data Coordinator (Consultant) Ortho-Clinical Diagno

stics Executed Data Management Study Start-Up activities, such as CRF design using Pag eMaker, testing Data Entry screens, writing Data Management Plans, Data Validati on Plans, testing the edit checks and declaring database ready for production; g enerated and resolved queries utilizing Oracle Clinical; interacted with the CRA and/or CRO to coordinate error resolution using Data Clarification Forms and de viation documents; trained and supervised Data Entry personnel; proofread and ed ited clinical databases; ensured the accuracy of deliverables from CRO personnel contracted to perform Data Entry and Data Management functions; provided techni cal and Data Management expertise as a member of a cross-functional project team ; worked with Data Management, the R&D and Technical Assay team to maintain logs correlating receipt of clinical data and samples; maintained Trial Master File and Site Regulatory File; participated in composing Company's SOPs; locked datab ases successfully and on time.

06/2006-08/2006

Senior Clinical Data Manager (Consultant) Cmed, Inc.

Managed clinical trial data for Phases I to IV; reviewed and tested eCRF screen

design, reviewed annotated eCRFs, written Data Management Plans for eDC and pape r based trials; generated and resolved queries; ensured adherence to relevant wo rking practices or standard operating procedures; tracked status and progress of Data Management for allocated projects/trials; communicated with the client reg arding various trial related topics. Achieved successful and on time eDC trials database releases.

06/2005- 06/2006

Clinical Data Manager II i3 Statprobe

As Lead Clinical Data Manager, was responsible for all Data Man agement processes from study start-up to database lock for individual clinical t rials; resolved and generated queries, also produced status reports by utilizing Oracle Clinical; Wrote and/or reviewed Data Management Plans, Data Validation P lans, Data Entry Guidelines for eDC trials and for paper trials; created, review ed, and processed Data Clarification Forms and updated the datasheets; was invol ved with CRF tracking by using e-Power system for paper studies and had input in designing e-CRFs for eDC studies; reviewed data listings, SAS datasets, SAS ext racts for various clinical trials; tested PDF screens for eDC trials, reviewed O C and SAS annotated CRFs before database release; was responsible for coding rev iew, SAE reconciliation process and lab data transfers for all of the various cl inical trials; liaised with clients and produced study progress reports. Accompl ished successful database locks by having low error rates after final QC proces ses. 08/2004-11/2004 Clinical Data Manager (Consultant) Novartis Pharmaceuticals Performed all aspects of database clean-up procedures by generating and resolvin g queries via Electronic Data Capture system; generated reports through IReview and directly via Phosco to facilitate the database clean-up process; attended st udy team meetings and participated in discussions on various study topics. Exec uted study's main objective in achieving favorable results within appropriate ti me frame for the Company's launching of a new drug. 06/2000-04/2004

Research Data Coordinator Abbott Laboratories

Executed all aspects of the Data Management process, from study start-up to data base lock; developed and implemented SOPs for Data Management guidelines and pra ctices; participated in coding process by utilizing MedDra Directory and TMS pro gram; locked many databases in a timely fashion; reviewed Clinical Case Report F orms, tables and listings for Interim and Final Analysis for accuracy and comple teness; ensured relevant tracking information is kept up to date; maintained stu dy documentation; written assigned project/study; creating Data handling Plans; maintained Oracle-Clinical Database by query monitoring system; implemented Labo ratory Data processes; organized and developed database auditing of clinical and non-clinical data; acted as a team leader on various projects; coordinated proj ect personnel; interviewed and trained new employees; served as a liaison betwee n cross-functional areas for Data Management team members, clients, and vendors domestically and internationally; attended all study team meetings and departmen tal meetings which also include teleconferences. Accomplished research studies' chief goals by a precise time and correct manner for the Company's imparting of a new drug.

1999-2000

Independent Consultant Berlex Laboratories, Inc.

Analyzed and coded serious adverse events by employing of Swaerr program and Har ts Dictionary; reviewed medical information for updating purposes; wrote medical case narratives; resolved labeling for event terms; prepared FDA safety reports . Carried into effect research's sense in a precise time and format for marketin g of a new drug.

1999-2000

Independent Consultant Forest Laboratories

Resolved for accuracy Discrepancies of Clinical trials Databases by using SAS pr ogram; re-examined clinical and non-clinical data; configured and transmitted qu eried routes; Assembled, unraveled and resolved data. Exhibited research's intent in an accura te and a definite time for the Company's launching of a new drug. 1999-2000

Independent Consultant Schering-Plough Research Insti

tute Encoded adverse events and concomitant therapies by using a Clinical program; ha d input in designing of clinical case report forms and protocols; reviewed lab d ata; examined Cives for accuracy; utilized Browdict dictionary for editing purpo ses. Presented research's intent in an appropriate time form and in a correct me thod for the Company's delivering of a new drug.

TECHNICAL SKILLS Oracle Clinical, eDC Systems such as Rave, Inform, Phosco, SAS, PageMaker, Clint rial, CRF WorkManager, iSpec, IReview, Microsoft Office. TRAINING - ACCOMPLISHMENTS 2008 2007

Inform PageMaker Training

2006

Oracle Clinical V4.5 User Training

2005

eDC System Training

2003

Oracle Clinical V4.03 User Training

2002

"Electronic Data Capture" - Society for Clinical Data Management Conference - Atlanta, GA

2000

Oracle Clinical V3.1.1 User Training

1994

Seminar - Neonatal Clinical Care Unit Procedures and Regulations