Manager Data
Resume:
DARLENE J. AUGUSTE
Stratford, CT 06614
acec8n@r.postjobfree.com
OBJECTIVE: Position as data manager or clinical research associate in the pharmaceutical industry.
QUALIFICATION SUMMARY:
• 10 years clinical data manager experience including coding and electronic data capture.
• Lead data manager experience and managed a small group of data managers for database locked.
• Nursing background including direct patient care, rehabilitation, maternity ward and pediatrics.
PROFESSIONAL HISTORY:
CLINICAL DATA SPECIALIST, Yale New Haven Health System, New Haven, CT 10//2010-Present
• Abstracts and reviews patients data for Yale New Haven Hospital (YNHH) ICU units
• Abstracts and reviews patients data for QOPI project (oncology) breast cancer, colon cancer, core data, and
Symptoms management
• Enter patients data, reviews edit checks and updates database for QOPI project (oncology)
• Meets and exceeds the customer expectations
• Partner with other team members, mobilizing resources to meet the needs of the department and the
organization
• Travels to multiple sites to observed the medical teams Time Out in the OR for patient safety
• Ensure all the medical team members anticipated on the Time Out and meet all the compliances
• Secret Hand Hygiene observation on the following sites YNHH, GH and BH to prevent infection and improve
patient safety
• Adapt to changes in department priorities such as; unexpected hospital audit needs
• changes to assigned project measures, LOA/vacation coverage
• Demonstrates positive verbal and non-verbal communication
• Interacts with internal and external customers in a respectful professional manner
• Assume responsibility and accountability independently for assigned project work that is related to the
Clinical Data Abstractor role
• Considers and uses a variety of approaches to complete work to meet data delivery schedules
• Identify new ideas and methods for saving resources and accomplishing work effectively and efficiently
CLINICAL DATA MANAGER Consultant, Hoffmann La Roche Nutley, NJ 01/2010-6/2010
• Develops and maintains effective working relationships with the Study Data Manager, Global Studies
Operations Manager, Global Studies Associate, Monitors of their assigned sites.
• Ensure full understanding of study documentation, including the protocol, in order to perform proper
execution of data management activities.
• Points to contact to Monitors for data flow, discrepancy management, and all other data management related
processes.
• Performs discrepancy management in accordance with the Study Data Quality plan.
• Executes data listing programs and reviews for patient data consistency, quality and completeness as defined
in the data Review Plan.
• Reviews discrepancies to ensure alignment with Data Review Plan.
• Identifies issues with validation procedures during study conduct and communicates findings to Study Data
Manager.
• Reviews and reconciles lab data.
• Reviews electronic Case Report Form (eCRF) in OC/MACRO (EDC) system.
• Reviews system-generated edit checks in OC/ MACRO (EDC) system.
• Run, prints and reviews tables and listings
• QC database listing, eCRFs and updated spreadsheets.
Therapeutic area : Rheumatoid Arthritis (RA)
CLINICAL DATA MANAGER Consultant, Novartis, East Hanover, NJ 12/2007 - 2/2008
• Provided input on CTT for review of clinical trial database design including user acceptance testing.
• Responsible for validation and analysis plan meeting, writing the study specific validation checks and reports.
• Identified inconsistencies and resolved them via the field monitor or directly with the investigational site .
• Reviewed and reconciled SAE and lab data. Reviewed data management portion of protocols.
• Froze data at appropriate time for statistical review, interim quality review, interim and final database lock.
• Presented at investigator meetings and trained sites on electronic database and study specific eCRF.
Therapeutic area: COPD.
CLINICAL DATA MANAGER, Averion, Rye Brook, NY 7/2007 - 12/2007
• Developed data management plan, data handling conventions, self-evident corrections, and edit checks.
• Performed data management review of CRFs for database and query validation. Reviewed data queries.
• Tested and validated all project specific programming and databases. Produced data clarification forms.
• Updated the DB and correct any erroneous data identified prio r to database lock. Participated in team
meetings
• Ran batch validation and track DCFs through data cleaning
Therapeutic areas: Oncology, Solid Lung Cancer.
CLINICAL DATA MANAGER Consultant, the Medicines Company, Parsippany, NJ 11/2006 – 6/2007
• Reviewed system-generated edit checks in Etrial. Monitored all revolved queries to blue triangle.
• Reviewed ECRF’s using EDC. Run, printed and reviewed preliminary tables and listings in Access.
• Reviewed and generated exception reports, lab data, DCF’s for all notes and discrepancies.
• Provided sites and monitors answers to questions on the protocol.
• Managed all data for the South East and Middle West Region in the U.S. Participated in team meetings.
• Coded adverse events, drugs, concomitant therapies and medical conditions, using medDRA.
Therapeutic area: Cardiovascular.
MEDICAL CODING SPECIALIST Consultant, SPRI, Kenilworth, NJ 5/2006- 8/2006
• Reviewed all encoded terms for accuracy and consistency within clinical studies and across clinical programs.
• Resolved inconsistencies noted.
• Maintained global terms and synonym tables.
• Coded drug information in UTD.
• Coded adverse events, lab data, medical history, surgical procedures, and disease terms in ClinTrial database.
• Responsible for overseeing dictionary maintenance and performing QC steps.
CLINICAL DATA MANAGER Consultant, RPS, Plymouth Meeting, PA 1/2006 - 4/2006
• Reviewed and Created DCF’s for all outstanding discrepancies in ClinTrial. Reviewed protocol and CRFs.
• Updated Annotated CRF’s per Data Clarification Forms. QC database listing, CRFs and updated spreadsheets.
CLINICAL DATA MANAGER Consultant, Bristol-Myers Squibb, Wallingford, CT 7/2002 - 12/2004
• Reviewed edit checks in QUERYMAN and ORACLE CLINICAL. Updated Clintrial per CRFs review.
• Ran Clintrial SQLASSIST listings and tracking reports. Reviewed and Created DCF’s in ORACLE
CLINICAL
• Provided Clinical Site Manager with appropriate protocol listings on a Routine basis and reconciled Lab data
• Participated in project team meetings, coded adverse events, concomitant therapies and medical conditions.
• Locked database for phase III. Managed DM for international and U.S sites in several protocols on a daily
basis
Therapeutic areas: Oncology, Breast Cancer & HIV
CLINICAL DATA MANAGER Consultant, PFIZER, Groton, CT, 11/2000- 05/2002
• Reviewed protocols and CRFs during design phase and provided technical guidance to ensure correctness.
• Created protocol project documentation folder. Submitted medical terms to dictionary group.
• Updated database generation using OC software. Generated and executed data queries.
• Resolved hand written queries in OC. Printed DCFs, ran edit checks. Closed DCFs in OC.
• Created Case Record Transmittal Form in Word for closed DCF’s. Reviewed processed error reports.
• Managed and created DCFs for all discrepancies with status of unreviewed. Resolved data entry problems.
• Ran and tested data validation procedure for new protocols in OC. Participated in weekly team meetings.
• Provide input into Case Report Forms (CRF) design and approve CRFs for production use. Oversee the design
of Oracle Clinical databases.
Therapeutic area: Cardiovascular.
CLINICAL CODING SPECIALIST, IPR, Norwalk, CT 1/2000-11/2000
• Recorded the appropriate code for Adverse Events, concomitant/therapies and medical conditions.
• Maintained issued product-specific reference lists while coding AEs, medications and medical conditions.
• Attended weekly Clinical Project Team meetings. Ensured codes within database are accurate.
• Managed auto-encoding processes and encoded all data requiring data management milestones
• Accountable for accuracy, consistency and completeness of all required encoding changes prior to DB lock.
Therapeutic area:
CLINICAL DATA ASSISTANT & CLINICAL COORDINATOR, IPR, Stamford, CT 8/1998 - 1/2000
• Generated, reviewed and processed error reports and data resolution forms. Reviewed computerized edit
checks.
• Reviewed monitoring reports, listing tables, DCFs and queried generation with SAS software.
• Interpreted and double entered medical data into a computerized database. Updated database through SAS.
• Verified correct spelling of medical terms, QC, and Level 1 corrections. Electronically filed for PID and
Cordis.
• Transcribed clinical data from CRF’s onto transcription sheets for outside data entry.
NURSING ASSISTANT, St. Joseph Medical Center, Stamford, CT 12/95 - 12/97
Evaluated the health status of patients, assisted patient’s with medications, communications skills, exercises, and
nutrition. Reviewed patient’s records with physicians. Took care of Alzheimer’s patients, assigned on Rehabilitation
and CCU. Assisted with patients on the Maternity and Pediatric floors.
SKILL
Microsoft office, EDC, Statistical Analysis System (SAS), Oracle Clinical, Clintrial, Inet, ClinAcess, WHO, ICD-9,
BNF Medical Dictionaries and the Internet. Flexible and fluent in terms of working with variety of database and
systems Fluent in French Good sence of leadership and communication
SPECIAL TRANING
eDM 2.o – Data Management
Good Clinical Practice and MedDRA (Medical Dictionary) Training
EDUCATION
Walden University Online, Master in Clinical Research Administration College of Health Science. Starting
September 4, 2012 Expected Graduation Date September 3, 2014
University of Bridgeport, Bridgeport, CT Major. Bachelor of Science in General Studies – 2012
Putnam University Westchester at Yorktown Heights, License Practical Nurse ( LPN) – 1997
Westchester College, White Plains, NY. Associate Degree in Computer Science and Technology. 1995
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