Manager Data

LEA SOYFER

** ***** **** ********, ** *****

862-***-**** *******@*********.***

CLINICAL DATA MANAGER

Determined, team-oriented professional with more than 13 years of experience in the pharmaceutical industry. Adept at determining project parameters, extracting the essentials, and achieving the desired results. Possesses the ability to adapt to any situation, and work well with others through effective communication and interpersonal skills. Experienced with many major softwares, data management tools and processes, and therapeutic areas.

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UAT Execution – eCRF Design – Edit Check Creation – Generation & Resolution of Queries – Tracking – Data Analysis – Generation of Listings – SAE Reconciliation – Medical Coding – Testing of DE Screens – Writing DMPs, DVPs & DE Guidelines – Training - Maintaining Trial Master File – Quality Assurance - Composing the SOPs – Testing PDF Screens – Reviewing Lab Data Transfers – Creating Forms – Writing Medical Case Narratives – Preparing FDA Safety Reports – Input on Designing Protocols – CRO Management - Project Management – Time Management

Manage Central Vendors – Manage Projects Budgets – Create and Manage Timelines

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PROFESSIONAL EXPERIENCE

10/2011 – Present Clinical Trial Operations Manager

Sanofi-Aventis, Inc.

Execute all study start-up activities for Phase I and Phase II trials; Manage CROs throughout the course of the trials;

Involve with preparation of timelines and CRO’s contracts;

Set-up database specifications such as CRF page tracking;

Writing of patient profile specifications; Review of extended

Protocol synopsis and amendments; Set-up impact requirements; Collaborate with study planner to set up Optime timelines; Perform Investigational Product management in collaboration with Investigational Product representatives; Prepare and lead medical review meetings; Run Sequel requests for data review; Prepare and lead corporate teleconference core meetings including follow-up of action items; Deliver monthly reports such as datasheets and recruitment curves; Contribute to statistical analysis meetings; Coordinate and plan all activities linked to database lock. Database lock was done successfully and on time for an investigational product.

06/2010-09/2011 Data Manager

Shionogi, Inc.

Perform clinical trial data management activities for various phases and therapeutic areas;

Manage CROs throughout the course of the trials;

Involve with preparation of timelines and CRO’s contracts;

Analyze study documentation such as DMPs, Edit check specifications, Coding listings, Analysis and Safety SAS datasets, Protocol Violations and Deviations reports, TLFs and CSR reports;

Maintain full responsibility in designing and generating

data line-listings and patient profiles from J-Review tool;

Execute study start-up activities for various Clinical

trials such as eCRF design, edit check specifications with

SDTM Compliance and UAT;

Active participation in all of the team meetings and

teleconferences;

Utilize Rave, Inform and other home grown systems

for various trials;

Involve with SOP development and production of

standard documentation such as DMP, and Edit check

specifications;

Direct involvement in successfully locking of three

databases and launching a FDA approved drug to the

market.

03/2008-04/2010 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 for several trials; generated IReview listings as needed for data review; executed SAE reconciliation for several trials; coded medical terms via AES system; locked and participated in database locks for several trials which were locked on time and with favorable results.

03/2007-10/2007 Clinical Data Coordinator (Consultant)

Ortho-Clinical Diagnostics

Executed Data Management Study Start-Up activities, such as CRF design using PageMaker, testing Data Entry screens, writing Data Management Plans, Data Validation Plans, testing the edit checks and declaring database ready for production; generated and resolved queries utilizing Oracle Clinical; interacted with the CRA and/or CRO to coordinate error resolution using Data Clarification Forms and deviation documents; trained and supervised Data Entry personnel; proofread and edited clinical databases; ensured the accuracy of deliverables from CRO personnel contracted to perform Data Entry and Data Management functions; provided technical 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 databases 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 paper based trials; generated and resolved queries; ensured adherence to relevant working practices or standard operating procedures; tracked status and progress of Data Management for allocated projects/trials; communicated with the client regarding 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 Management processes from study start-up to database lock for individual clinical trials; resolved and generated queries, also produced status reports by utilizing Oracle Clinical; Wrote and/or reviewed Data Management Plans, Data Validation Plans, Data Entry Guidelines for eDC trials and for paper trials; created, reviewed, and processed Data Clarification Forms and updated the datasheets; was involved 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 extracts for various clinical trials; tested PDF screens for eDC trials, reviewed OC and SAS annotated CRFs before database release; was responsible for coding review, SAE reconciliation process and lab data transfers for all of the various clinical trials; liaised with clients and produced study progress reports. Accomplished successful database locks by having low error rates after final QC processes.

08/2004-11/2004 Clinical Data Manager (Consultant)

Novartis Pharmaceuticals

Performed all aspects of database clean-up procedures by generating and resolving queries via Electronic Data Capture system; generated reports through IReview and directly via Phosco to facilitate the database clean-up process; attended study team meetings and participated in discussions on various study topics. Executed study’s main objective in achieving favorable results within appropriate time 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 database lock; developed and implemented SOPs for Data Management guidelines and practices; participated in coding process by utilizing MedDra Directory and TMS program; locked many databases in a timely fashion; reviewed Clinical Case Report Forms, tables and listings for Interim and Final Analysis for accuracy and completeness; ensured relevant tracking information is kept up to date; maintained study documentation; written assigned project/study; creating Data handling Plans; maintained Oracle-Clinical Database by query monitoring system; implemented Laboratory Data processes; organized and developed database auditing of clinical and non-clinical data; acted as a team leader on various projects; coordinated project personnel; interviewed and trained new employees; served as a liaison between cross-functional areas for Data Management team members, clients, and vendors domestically and internationally; attended all study team meetings and departmental 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.

Previous positions include:

Medical Research Associate – AMA Laboratories, Inc.

FORMAL EDUCATION

M.D. Degree in General Medicine and Surgery, 3.7 GPA

Autonomous University of Guadalajara, Mexico Medical School

B.A. Degree in Biology, 3.5 Major GPA

Queens College of the City University of New York

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TECHNICAL SKILLS

Oracle Clinical, eDC Systems such as Rave, Inform, OC/RDC, Phosco, SAS, PageMaker, Clintrial, CRF WorkManager, iSpec, IReview, Microsoft Office.

REFERENCES AND FURTHER DATA PROVIDED UPON REQUEST

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