Manager Data

PROFESSIONAL SUMMARY

Goal- oriented professional with over 11 years of clinical data management experience which includes 6 years of lead experience from database start-up to database lock and 8 years of study coordinator experience. Exceptional expertise in electronic data capture, data entry, great time management and organizational skills and outstanding client services.

TECHNICAL AREAS OF EXPERTISE

• Microsoft Access, Oracle Clinical, RDC, ClinTrial, EDCSAS (Base)

• Windows 95/98/NT/2000/XP/7

• iVal and Acceliant

• MS Word, Excel, PowerPoint, Project, Outlook, Outlook Express, Lotus Notes, Medic, Clintrack, ClinBase

• ICD9, Who DRUG, and MedDRA

THERAPEUTIC EXPERIENCE

• Infectious/Parasitic Disease: HIV/AIDS

• Oncology: Breast Cancer, Lung Cancer

• Endocrine/Metabolic: Diabetes, Gout

• Hematology: Deep Vein Thrombosis (DVT)

• Dermatology: Eczema, Psoriasis

• Genitourinary: Birth Control

• Cardiovascular: Coronary Heart Disease (CHD)

• Central Nervous System (CNS)/ Psych: Depression, Alzheimer’s Disease, Epilepsy, Huntington’s Disease

• Musculoskeletal Disease: Osteoarthritis, Multiple Sclerosis

• Pain/Analgesia: Rheumatoid Arthritis

• Respiratory: Chronic Obstructive Pulmonary Disease (COPD)

• Healthy Patients

EXPERIENCE

2011 to Present Ockham Cary, NC

Clinical Trial Annotation Specialist

• Develop Study Data Tabulation Model (STDM) annotation on legacy Case Report Forms(CRF) using Clinical Data Interchange Standards Consortium (CDISC) for over 50 studies

• Assist with updates on Case Report Forms annotation from SAS to Study Data Tabulation Model (STDM) for Clinical Data Interchange Standards Consortium (CDISC)

• Perform Quality Control review on peer’s Study Data Tabulation Model (STDM) Annotation

• Serve as a go to person for questions concerning Study Data Tabulation Model (STDM) Annotation on legacy Case Report Form (CRF) in Clinical Data Interchange Standards Consortium (CDISC)

2010 to 2011 Pharmanet Cary, NC

Data Analyst – (Contact)

• Performed data review and query generation

• Tracked study progress and issue periodic status reports

• Updated the database to correct errors

• Processed electronic data received from outside vendors

2006 – 2009 PPD Morrisville, NC

Clinical Data Manager II – (2008 – 2009)

• Performed as lead clinical data manager of assigned projects

• Compiled edit specifications, data management plans, data review guidelines, quality control plans and Clinical Data Interchange Standards Consortium specification

• Developed and performed checks on clinical data in accordance with study specific guidelines to ensure validity (i.e. Data Review guidelines, Quality Control Plans, Data Management Plans CDISC)

• Managed timelines, budgets and all financial for all assigned studies in data management

Clinical Data Manager I – (2006 – 2007)

• Acted as lead clinical data manager for multiple projects and provided support

• Coordinated with clients and colleagues in other functional groups

• Fulfilled all data management cleaning activities in accordance with data validation manual and/or client documentation

• Delegated tasks appropriately within team

2006 Digital Infuzion Gaithersburg, MD

Protocols Specialists – (Contract)

• 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 and supplying information such as names of key people, organizations, companies involved with trials, and updating website

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

2005 INC Research, Inc. Raleigh, NC

Clinical Data Associate II – (Contract)

• Acted as 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

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

2004 to 2005 PRA, International Charlottesville, VA

Clinical Data Coordinator – (Contract)

• Participated in validation of clinical database

• Processed and reviewed data of subject enrolled in protocol

• Reviewed data discrepancies within clinical databases

• Generated and tracked queries or data clarification forms along with correcting clinical databases in accordance with edit specifications and query replies

2001 – 2004 Parexel International Baltimore, MD

Senior Clinical Data Manager – (2002 to 2004)

• Served as a Project Lead while representing department at client meetings and presentations

• Supervised and trained clinical data managers and data entry personnel

• Provided consultation for case report form design and site instructions

• Assisted with clinical trial that was not rewarded to Data Management by assisting with CRF transcription, meals, and vitals

Clinical Data Manager – (2001 to 2002)

• Designed, developed, and programmed databases in Microft Access and iVal to capture clinical data from Phase I studies

• 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 Standard Operating Procedures compliance

• Trained staff on Standard Operating Procedures and data management techniques, skills, and tools

EDUCATION

Master of Science in Clinical Research Administration expected 2013

Walden University Baltimore, MD

Master of Business Administration in Health Care Administration 2010

American InterContinental University Hoffman Estates, IL

Bachelor of Science in Biology 1997

Elizabeth City State University

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