Data Manager

BRIAN WEBER

Home/Cell #773-***-****

PROFESSIONAL EXPERIENCE

Dec 2007– Sept 2011

Kendle International, LLC. Chicago, IL, a fully owned subsidiary of INC Research, LLC (Acquired by INC Research, LLC July 12, 2011)

Senior Clinical Data Associate

-Reviewed and processed clinical trial data to ensure the accuracy and consistency of clinical databases. - Commonly performed the following data related activities: CRF tracking, reviewing, validation, updating, SAE reconciliation, lab data reconciliation and safety coding (including MedDRA & WHO Drug). - Provided accurate, timely, and consistent clinical data to both sponsors and other internal departments to support the business needs of Kendle. - Participated in the training of Clinical Data Associates. - Reviewed and generated ad hoc listings, reports and quality control documentation to facilitate validation of the clinical database. - Led teams of multiple CDAs and exhibited leadership skills.

Feb 2007 - Nov 2007

RPS, Inc. (contracted to TAP Pharmaceuticals)

Clinical Data Associate

-Created the Data Review Plan for each study database in conjunction with a clinical team member. - Also, designed and created the validations used for each study database to ensure the quality of the clinical data

- Was responsible for meeting all timelines related to studies and tasks assigned to them- Worked exclusively in an all-EDC (Medidata Rave) environment along with IVRS & proprietary databases designed to assist in issuing queries, query resolution, errata discovery between interrelated studies (rollovers, et. al.), and other details to ensure a clean subject database.- Assisted in all ways to release and lock databases (including QA, QC, testing of new databases, etc.) -Was responsible for the quality of data in all assigned studies and study databases. - Maintained the study documentation for each database

Jun 2006 - Feb 2007

Kendle International, Inc., Northbrook, IL USA

Clinical Data Associate II

-Maintained and organized complete and up-to-date study documentation for the project team. - Operated computer software, such as lab and clinical databases, to review data, generate reports and update data. -Tracked and reconciled data received for in-house review through use of CRF tracking tools. - Applied corrections and/or updates to the clinical database and appropriate documents (original and/or working copies of CRFs) that are identified through query resolution, data entry, text review, site request, computerized validation and/or data importing. - Performed reconciliation of similar data between multiple data sources.- Coded clinical trials data (e.g., adverse events, medical history, physical examination and/or concomitant medications) for projects where Kendle CDM was responsible for coding safety data.- Generated and/or reviewed listings to check accuracy and completeness of coded

clinical data. - Performed internal CDM QC audits of the clinical database against the CRFs including query results. - Participated in the definition, development, and validation of internal CDM QC audit sheets, listings and/or reports and ad hoc listings, reports and queries for use in the quality control of the clinical database. - Maintained internal CDM QC documentation and produced QC audit report including calculating accuracy rate. - Assisted the Clinical Data Manager (DM) in the identification of clean patients for QC. - Created QC listings from clinical database

Oct 2005 - Jun 2006

Clinforce (contracted to Kendle International, Inc., Northbrook, IL USa)

Clinical Data Associate I

-Reviewed and processed clinical trial data to ensure the accuracy and consistency of clinical databases. - Regularly performed data-related activities such as CRF tracking, reviewing, validation, and updating. - Provided accurate, timely, and consistent clinical data to both sponsors and other internal departments to support the business needs of Kendle.

Apr 2005 - Jul 2005

Morton Grove Pharmaceuticals, Morton Grove, IL USA

Regulatory Affairs Associate

-Was responsible for reviewing, processing, compiling, submitting, and archiving paper and/or electronic documents required for new, pending, and approved ANDAs & NDAs for MGP products in accordance with 21CFR314.- Assisted in preparation of responses to CMC deficiency letters and other negotiations with the FDA. - Assisted in preparation and review of Annual Reports, Supplementals, and Amendments for submission to the FDA for MGP products.Involved with writing, editing, and proofreading of Informed Consent forms, Patient Diaries, and study Protocols for upcoming domestic and international clinical trials for existing and potential MGP products. -Developed and organized spreadsheets, charts, and Word© documents to be used as tools to solidify the structure and reorganization of the Regulatory team within Morton Grove Pharmaceuticals.

Oct 2002 - Jan 2005

Advanced Clinical Research Services, Lincolnshire, IL

Clinical Data Manager / Data Entry Operator

Clinical Data Manager

-Created, prepared, and maintained study-related documents including database validations, data processing plans, study conventions, etc. - Communicated and met with clients, clinical sites, investigators, study coordinators, and entry staff regarding study issues, timelines, Case Report Forms (design & content), etc. - Oversaw quality control and quality assurance for the studies assigned. -Issued, resolved, and tracked queries while ensuring their resolution by end of study/ database lock. - Revised, proofed, and reviewed SOPs (Standard Operating Procedures) and CRFs (Case Report Forms)

Data Entry Operator

-Researched and identified data elements from multiple clinical studies for system input. - Translated clinical study CRFs into the Oracle Clinical Database (from EDC PDF files or hard copy). - Clarified and/or corrected any ambiguities, misspellings, or discrepancies while following SOPs and study & global conventions.

Oct 2000 - Dec 2001

Takeda Pharmaceuticals N.A., Lincolnshire, IL

Proofreader – Labeling Operations / Submissions Coordinator

Proofreader – Labeling Operations

-Proofread and edited all commercial, promotional, and sample labeling, package inserts, and brief summaries. - Assisted in the creation and revision of SOPs pertaining to labeling and other regulatory matters. - Developed and maintained Labeling Operations tracking systems and files. - Assisted in the compilation, editing, processing, and proofreading of revised package inserts and brief summaries for sNDA submissions (to the FDA).

Submissions Coordinator – Regulatory Affairs

-Assembled and shipped daily submissions for all drug compounds to the FDA and Takeda corporate headquarters. - Reviewed and proofed submission quality for completeness and accuracy. - Involved in the submission of several INDs as well as many sNDA supplementals. - Ensured proper tracking, filing, and archiving of all compound submissions

Feb 2000 - Oct 2000

Advanced Clinical Services (contracted to Takeda Pharmaceuticals)

Data Coordinator – Product Safety

-Reviewed, edited, and compiled coherent narratives concerning adverse events onto Med Watch© forms for FDA review. - Headed several special projects to maintain accurate recording and submission of adverse event data

Mar 1999 - Jul 1999

Option One (contracted to TAP Holdings, Bannockburn, IL)

Proofreader

-Head proofreader for a New Drug Application to FDA

THERAPEUTIC EXPERIENCES

Endocrinology

Endocrinology - Adults Growth Hormone Deficiency

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Endocrinology - Male Sexual Dysfunction

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Endocrinology - Type 2 Diabetes Mellitus

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Gastroenterology

Gastroenterology - Crohn's Disease

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Gastroenterology - Reflux Esophagitis

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Hepatic Disorders/Liver

Hepatic Disorders/Liver - Hepatitis B

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Oncology

Oncology - Brain Cancer

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ADDITIONAL EXPERIENCES

CDISC Experience

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Medidata RAVE EDC – CDM

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Oracle Cliniical RDC - CDM

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Pediatric Experience

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TrialBase Experience

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EDUCATION

1985

Lake Forest College - United States

Bachelor - English- Writing

BIOGRAPHY

Brian Weber was, in his last position, a Senior Clinical Data Associate with Kendle International, providing accurate, timely, and consistent clinical trial data to both sponsors and other internal departments to support the business needs of Kendle. He was also involved in the leadership and training of Clinical Data Associates and the data-related activities of CRF tracking, reviewing, validation, updating, SAE reconciliation, lab data reconciliation, and safety coding. Prior to that, Brian worked as a contracted Clinical Data Associate at a Chicago-based pharmaceutical company, at Kendle prior to that, and also in Regulatory positions at two other Chicago-based pharmaceutical companies. Brian began his work in Clinical Data Management in Data Entry and then as a Clinical Data Manager at a Clinical Research Organization based in Lincolnshire, IL.

Brian graduated with a Bachelor of Arts degree from Lake Forest College in 1985. His degree is in English/Writing.

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