Quality Control Data

VANESSA PLEASANT

*** **** **** ** • Cary, North Carolina 27513 • 678-***-****

QUALIFICATIONS SUMMARY

Very detailed-oriented professional with over ten years of experience in data management and pharmaceutical research industry.

• Demonstrate the ability to evaluate priorities and responsibilities to determine the actions necessary for ensuring timely deliverables.

• Expertise in addressing and solving initial problems related to document flow process, equipment dysfunction, abnormal pending requests or unforeseen situations without delay.

• Skilled at understanding the work and processes in a sufficient way to be able to follow specific standard operating procedures consistently with the general conventions.

• Proficient with Microsoft Office System (including Microsoft Word, Excel, PowerPoint, Access, and Outlook). Knowledgeable of Medical Terminology, Oracle Clinical, Clintrace, Empirical Trace, Business Objects, Query Builder, CRF Navigator, FoxPro Database System, Clintrial 4.3, DataFax, Argus Database, InForm, Medidata, Business Standard Operating Procedures, Clinical Data Management Working Instructions and Business Standard Conventions and Applications.

PROFESSIONAL EXPERIENCE

Quintiles/Clinforce, Inc. – Morrisville, North Carolina (Contract)

Associate Operations Specialist (Jan-2011 to Jan-2012)

• Review and process data from various sources on time, within budget and meet quality standards

• Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, and generate queries pertinent to the case.

• Perform quality control, driving case closure, and coordinating translations.

• Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.

• Perform other duties as assigned.

UCB, Inc./Clinforce, Inc. – Smyrna, Georgia (Contract)

Drug Safety Coordinator (Nov-2008 to Oct-2010)

• Encode cases in Global Clinical Safety & Pharmacovigilance database and prepare case narratives that reflect data received.

• Perform duplicate checks upon case receipt and acknowledgement to sender.

• Review source documents to detect inconsistencies or discrepancies in data entry from clinical trials, spontaneous sources, and license partners.

• Produce regulatory report forms for distribution or filing.

• Query data inconsistencies.

• Send queries to the sites, and assist sites with completion and follow-up on outstanding queries to ensure case completion.

• Send serious cases to affiliates and/or licensees.

UCB Inc., Data Management – Smyrna, Georgia (Layoff)

Sr. Clinical Data Processor (Mar-2004 to Sep-2008)

• Trained and mentored newly hired data processors in performing the function of entering clinical data into company Clinical Data Management System and scanning case report forms, external pages and data clarification forms for browsing and for the purpose of submission to regulatory authorities.

• Entered data as described in the user guides and follow the Data Entry Conventions, being very rigorous in the application of all instructions.

• Created test patient data to test screen design functionality and database structure, and document the testing.

• Reviewed the audit trail of data entry changes to ensure that updates made to the clinical database were an accurate reflection of the case report forms and data clarification forms.

• Received, processed, and filed case report forms (CRFs) and Data Clarification Forms (DCFs) in an appropriate manner.

• Initiated queries to the investigational site regarding information received that were illegible, incomplete or incorrect.

• Assisted with the interviewing/hiring process of new applicants.

Duke Clinical Research Institute, ACOSOG Group – Durham, North Carolina

Clinical Data Assistant II (Oct-2003 to Mar-2004)

• Performed/initiated comprehensive data management tasks, pertaining to the Data Management Plan.

• Performed/initiated comprehensive quality control procedures.

• Provided data management expertise and data coordination process improvement to Clinical Data Management department.

• Mentored other team members in training and developing data management expertise.

• Interacted with corporate team and CDM team members to negotiate timelines and responsibilities.

• Assisted in developing, revising, and maintaining core operating procedures and working instructions.

• Complied with core operating procedures and working instructions.

Duke Clinical Research Institute, Data Management – Durham, North Carolina

Clinical Data Assistant I (Sep-2001 to Oct-2003)

• Assisted in ensuring the integrity of clinical trial databases.

• Performed/initiated comprehensive quality control procedures.

• Assisted in basic data review and basic quality control procedures.

• Wrote/resolved data clarifications as directed by the Lead Data Manager.

• Ensured that personal project objectives were met and informed Lead Data Manager of problems.

Duke Clinical Research Institute, Clinical Trial Services – Durham, North Carolina

Clinical Trials Assistant II (Mar-1997 to Sep-2001)

• Provided central support to the site management team for designated activities, including coordination and maintenance of project documentation, tracking and information retrieval.

• Set up and maintained project documentation files.

• Supported tracking systems and coordinated communication both internally and externally.

• Produced and distributed financial reports, coordinated team and customer meetings, maintained project timelines.

• Assembled drug kits for studies as needed

Duke Clinical Research Institute, Clinical Events Classification – Durham, North Carolina

Clinical Trials Assistant I (Jan-1993 to Mar-1997)

• Assisted team members with designated administrative tasks in support of clinical trial execution and management.

• Reviewed information collected from patient charts, medical records, interviews, questionnaires and Adverse Event/Serious Adverse Event reporting for accuracy.

• Ensured the accurate evaluation and quality assurance of collected data, and preparation of appropriate documentation.

• Evaluated and interpreted collected clinical data in conjunction with the Principal Investigator.

• Identified problems regarding data entry and forms logging and made recommendations for improvement.

EDUCATION AND TRAINING

• Ashford University-Clinton, IA- Healthcare Administration-Bachelor’s Degree, 2011

• University of Phoenix- Phoenix, AZ-Arts in Business-Associates Degree, 2009

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