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Senior Clinical Data Manager

Location:
Rockville, Maryland, United States
Posted:
March 29, 2008   all resumes
Email:
l5pjh8@r.postjobfree.com
Contact Info:
*************@***.***


Liah S. Ayungo
l5pjh8@r.postjobfree.com

Summary:

• Demonstrated knowledge of the Pharmaceutical environment,
understanding the job functionality of multiple working groups.
• Quick to learn new concepts, works well under pressure.
• Computer knowledge of multiple programs and databases.
• Strong educational background in the sciences.


Education:
B.A. Degree in Psychology (Focus on Neuroscience)
University of Pennsylvania, Philadelphia, PA
1998

Career History & Accomplishments:

Senior Data Manager, Human Genome Sciences March 2008-Present
(In addition to the responsibilities listed below)
• Present data issues to global sites to improve data quality
• Work on task force to define locking requirements for the EDC database
• Monitor metrics of the Phase III EDC database for errors or trends in
missing data.

Data Manager, Human Genome Sciences March 2005-March 2008
(In addition to the responsibilities listed below)
• Work with Phase III Infectious Disease Trials
• Review Edit Specifications for electronic data capture Database
• Perform UAT on programmed Edit Specifications for electronic data
capture database
• Provide training to CRA and Study Coordinators on electronic data
capture system.
• Prepare clinical data for review for Data Monitoring Committee (DMC)
and/or Interim Analysis reviews

Senior Data Coordinator, Human Genome Sciences February 2004 – March2005
(In addition to the responsibilities listed below)
• Ensuring protocol standards are met from study start-up to database
lock and communicating information and issues to involved parties to
ensure that site management activities, protocol execution and study
documentation is in compliance with study timelines, ICH-GCP
guidelines, standard operating procedures and local regulatory
guidelines or regulations
• Involved in developing Data Management Standard Operating Procedures
and Processing Guidelines
• Serve as Data Management representative in team project meetings

Data Coordinator, Human Genome Sciences December 2002 – March2004
(In addition to the responsibilities listed below)
• Work with Phase I and II Oncology clinical trials
• Responsible for disseminating information to appropriate team members
to ensure timelines are met
• Use SQL statement through Clintrial Retrieve Module to retrieve data
reports required by the project team (as appropriate)
• Prepare Data Management Plan and Data Management timelines
• Write Edit Checks to generate automatic queries
• Design Case Report Forms (CRFs) to insure proper data collection

Junior Data Coordinator, Human Genome Sciences January 2002 – March 2004

(In addition to the responsibilities listed below)
• Work with Phase I and II Oncology clinical trials
• Oversee data review, and database finalization
• Review Case Report Form (CRF) data for completeness, accuracy and
consistency
• Identify and resolve data discrepancies; as appropriate, apply
corrections to CRFs
• Update/correct/review data in the clinical databases based on resolved
data queries
• Validate CRF data entered and verified

Clinical Study Coordinator, NOVA Research Company March 2001 – December 2001

• Serve as the primary NIH Contact for protocol participants
• Assure arrangements for appointments, transportation, and procedures
and other patient-related matters
• Organize and perform protocol tests and procedures.
• Assist and coordinate the activities of investigators, support staff,
monitors, consultants, boards and all others concerned with the
conduct of this study
• Establishing guidelines and checklists to ensure adherence to study
protocol
• Created and maintain a system of records and reports in conformance
with the needs of the research as well as the rules and regulations
governing NIH clinical studies. This involves assistance with the
collection, inputting, formatting, analysis, storage and distribution
of the protocol information as well as the generation of data
collection and transmittal formats and informatic systems
• Maintain patient charts and data
• Maintain surveillance of study related activities, results and
documentation to assure compliance with the protocol, good clinical
practice,ethical standards and other controlling rules, regulations
and authorities.
• Prepare and transmit study information to institutional and regulatory
authorities in compliance with protocol provisions, NINDS and NIH
rules, FDA requirements and other legitimate requests. These include
protocol amendments, informed consent revisions, annual review of
protocol, progress and adverse event reports.

Research Coordinator, Treatment Research Center November 1999 – March 2001
• Assisted in pharmaceutical studies and clinical research trials
related to pharmacological adjuncts for substance abuse recovery
• Developed study protocols and consent forms for submission to
regulatory and funding agencies
• Developed of Case Record Forms
• Developed of a schedule of assessments
• Established guidelines and checklists to ensure adherence to study
protocol
• Reported site enrollment data
• Trained and supervised student workers
• Conducted group therapy sessions
• Recruited and interviewed patients
• Processed blood and urines
• Maintained patient charts and data

Counselor/Research Coordinator, Thomas Jefferson University November 1998 – November 1999
• Conducted a year long clinical research trial related to substance
abuse recovery at the Narcotics Addiction Rehabilitation Program
• Administered questionnaires *Distributed protocol consent
• Tracked patient data
• Conducted follow-up interviews
• Motivated patients to complete treatment plans and meet monthly goals

Research Assistant Center for Psychotherapy Research October 1994 – November 1998
• Assisted in research trials
• Collected and entered patient data
• Distributed protocol consent
• Tracked patient data
• Conducted patient follow-up interviews

Memberships & Affiliations:

• NOPCAS
• DIA
• SCDM

Skills:

• Proficient in Microsoft Word, Microsoft Excel, Power Point, Internet ,
Microsoft Project
• Clintrial 4.2, 4.3
• CRF Work Manager (Integic scanning system)
• Completed Good Clinical Practices Training
• Trained to administer the Addiction Severity Index
• eCaselink EDC system