Manager Data
Resume:
Carolyn J. Brideau
Middleboro, MA 02346
OBJECTIVE: To continue a career in clinical within a progressive organization.
QUALIFIED BY:
• Monitored several clinical studies to ensure compliance with protocol and
overall clinical objectives. Oncology, hemophilia, cardiovascular, human
growth hormone, medical devices on the knee, spine, and heart.
• Collaborated with the team in protocol development, investigator
recruitment, site management.
• Traveled to sites for study start up, monitoring, and close out of studies.
• Presented and participated in several cadaver labs for medical devices
• Developed several case report forms for a variety of clinical studies
• Trained investigators and clinical coordinators on study activities
• Reviewed CRFs for completeness and accuracy
• Managed and resolved data queries with site personnel
• Possess a sound knowledge of medical terminology, FDA Regulatory
Requirements, and Good Clinical Practices (GCPs.) of clinical reports
• Participated in discussions with third party vendors such as central
laboratory to define required file format and content specifications for
electronic files
• Supported and assisted Clinical Research Associates, Data Assistants and
other Data Managers with EDC trials
• Participated in ACRP training courses and Barnett training courses
EDUCATION: April, 2009 to Present – Presently taking the certified monitoring clinical
study course. Certification course consists of drug development, initiating
the study, monitoring the study, and closing out the study. Certified exam
scheduled for mid July, 2009.
B.S., Physiology, Bridgewater State College
CRA QUALIFICATIONS: Started my career at Serono Laboratories, Norwell, MA
• Clinical Research Associate (three years total)
• Monitored clinical studies to ensure compliance with protocol and overall
clinical objectives within the U.S.
• Trained investigators and clinical coordinators on study activities
EMPLOYMENT EXPERIENCE:
October 2008 to April, 2009Transmedics North Andover, MA
Perm – Sr. Clinical Data Manager
• Worked closely with a CRO in regards to various CRA and CDM tasks for
Phase III and Phase IV heart studies.
• Reviewed source documents and case report forms
• Responsible for generating data clarification forms
• Reconcile serious adverse events
Jan 2007 to June 2008 Contracted at Dyax Corporation, MDCI CRO, and Genzyme
Contracted – Sr. Clinical Data Manager
• Supported and assisted Clinical Research Associates and Data Managers
with EDC trials
• Freeze and locked data as appropriate in time for statistical review and final
database lock
• Review tables/listings for cardiovascular submissions
October 2003- May 2006 DePuy Biologics Medical Devices ( a Johnson & Johnson Company)
Raynham, MA (permanent)
Sr. Clinical Data Manager
• Worked closely and managed with a CRO to have six Oracle Clinical
databases built and validated before first CRF in for each study
• Designed and finalized CRFs, CRF completion and data entry guidelines in
collaboration with the Primary CRA
• Trained data management personnel and contractors in the design of CRFs,
review of CRFs, data entry, and discrepancy management
• Managed data management timelines and deliverables for Oracle Clinical
database builds, and annual reports
• Created work instructions (WI) for data management from study start up
through database lock
• Interacted with third party vendors such as CROs to implement edit
specifications for electronic transfers
December 2001 – Wyeth Research Cambridge, MA
October 2003 Clinical Data Manager II
• Assisted in creating databases using Clintrial 3.3
December 1996- 2001 Thayer Academy Braintree, MA
Science Teacher and Math teacher (8th and 9th grade)
• Taught various topics within the science and math curriculum
• Coached girl’s basketball and softball teams
December 1991 toParexel International Corporation Waltham, MA
September 1996 Clinical Data Manager
• Established procedures for the design and flow of CRFs, data clarification
forms, and data edit checks
• Served as Primary contact for various clinical studies
COMPUTER EDUCATION: Microsoft applications, SAS 8.3 (basic knowledge), Clintrial 3.3,
CRF MS, Oracle Clinical, EDC applications, Quickbooks
ACHIEVEMENTS: Received the Standard Of Leadership award and Encore award
recognizing the achievement of exceptional business results by demonstrating
outstanding behaviors by DePuy Biologics
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