Wendy Mason

**** ** *** ** ******, NC ***** 252-***-**** ablkco@r.postjobfree.com

SUMMARY OF QUALIFICATIONS

* ***** ** ******** **** management, including:

• 5 years of lead experience from database start-up to lock

• Expertise in Phases I in variety of therapeutic areas

• 8 years of study coordinator experience

• Strong working knowledge of GCP

• Acquainted with electronic data capture and remote data entry systems

TECHNICAL KNOWLEDGE

Databases: MS Access, Oracle Clinical, RDC, ClinTrial, EDC

SAS Modules: SAS (Base)

Operating Systems: Windows 95/98/NT/2000

Data Management Systems: iVal and Acceliant

Additional Software: MS Word, Excel, PowerPoint, Project, Outlook, Outlook Express,

Lotus Notes, Medic, Clintrack, ClinBase

Coding Dictionary: ICD9, Who DRUG, and MedDRA

PROFESSIONAL EXPERIENCE

PHARMANET CARY, NC

Data Analyst (Contractor) 07/2010-present

• Define edit checks to be programmed for the study/project

• Review programmed edit checks

• Track study progress and issue periodic status reports

• Update the database to correct errors

• Code Case Report Form (CRF) verbatim terms using PharmaNet or sponsor-supplied

dictionaries

• Process electronic data received from outside vendors

• May assist in the review of the database design

PPD Morrisville, NC

Clinical Data Manager II 01/2008-07/2009

• Performed as lead clinical data manager of assigned projects

• Coordinated clinical data management project deliverables

• Developed and performed checks on clinical data in accordance with study specific guidelines to

ensure validity

• Performed quality control activities by making sure all necessary project documentation was

created and filed correctly

• Managed data management project budget and timelines

• Assisted in centralization of all off-site records within Wilmington location as part of GRIN, Global

Records Initiative Project

• Served as key player for Data Entry of Master Tracker

Clinical Data Manager I 12/2006-12/2007

• Acted as lead clinical data manager for multiple projects, providing support to other CDM

• Liaised with clients and colleagues in other functional groups

• Fulfilled all data management cleaning activities in accordance with Data Validation Manual

(DVM) and/or client documentation

• Designated tasks appropriately within team

Digital Infuzion Gaithersburg, MD

Protocols Specialists 07/ 2006-12/2006

• Compiled and maintained AIDS clinical trial information in central repository

• Abstracted protocols into Enterprise Data Collection Center

• Served as point of contact for study sites responsible for supplying information such as names of

key people, organizations, and companies involved with trials

• Completed entry of all of legacy protocols and discrepancies between old versions and new

version of protocols

• Updated and kept track of changes in SOPs and work manual

• Served as point of contact for updating Enterprise Data Collection Center website

INC Research Inc. Raleigh, NC

Clinical Data Associate II 03/2005-09/2005

• Acted as trial Lead Data Manager during conduct of clinical trial

• Developed and implemented study-specific Clinical Data Management Plans

• Performed user test plans/user testing for data entry and edit checks

• Used strong working knowledge of clinical database design and structure to facilitate data review

activities

• Tracked production and communicated issues to project team/management

• Maintained scope of work and notified management of changes concerning the study

• Worked on project team and complied with all SOPs, regulatory guidelines and directives, and

study specific plans pertaining to collection, review, and management of clinical data

PRA, International Charlottesville, VA

Clinical Data Coordinator 11/2004-03/2005

• Participated in validation of clinical database

• Processed and reviewed CRF data of subject enrolled in protocol

• Served as consultant on other data management projects in-house

• Reviewed data discrepancies within clinical databases

• Generated and tracked queries, or data clarification forms

• Corrected clinical databases in accordance with edit specifications and in response to query

replies

Parexel International Baltimore, MD

Senior Clinical Data Manager 05/2002–11/2004

• Represented department at client meetings and presentations

• Supervised Clinical Data Manager and other data management personnel

• Provided consultation for case report form design and site instructions

• Coded adverse events, medications, and other specified clinical variables using Medra,

Constart, Whoart, and Whodrl

• Cleaned laboratory data

• Wrote and trained Clinical Data Management personnel on SOP

• Assisted with clinical trial that was not rewarded to Data Management by assisting with CRF

transcription, meals, and vitals

Clinical Data Manager 02/2001-05/2002

• Designed, developed, and programmed databases in MS Access and iVal to capture clinical data

from Phase I studies

• Prepared Data Management documentation and marketing surveys for potential clients

• Represented Clinical Data Management on site visits to potential clients and managed internal

resource allocation for studies and project timelines

• Conducted internal process audits and reviews of Data Management SOP compliance

• Trained staff on SOPs and Data Management techniques, skills, and tools

OTHER RELATED WORK HISTORY

Clinical Research Associate (Contractor), Parexel International, Baltimore, MD 10/2000-12/2000

Associate Clinical Data Coordinator, Quintiles, Durham, NC 05/2000-09/2000

Medical Assistant, City Cardiology & Internal Medicine, Roanoke Rapids, NC 10/1999-05/2000

Medical Assistant, NC Eye & Ear Hospital/Clinic, Durham, NC 01/1999-10/1999

EDUCATION

American InterContinental University Hoffman Estates, IL

Master of Business Administration Expected: 09/2010

• Concentration: Healthcare Management

Elizabeth City State University Elizabeth City, NC

Bachelor of Science in Biology 07/1997

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