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Senior Clinical Data Manager

Location:
Rockville, Maryland, United States
Posted:
March 29, 2008
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