Title:Minh-Duc Nguyen

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Name: Minh-Duc Nguyen

Address:

City: Escondido

State: CA

Zip/Postal Code: 92025

Country:

E-mail: abpsls@r.postjobfree.com

Primary Phone:

Background

Most Recent Job Title: Associate Director of Quality

Most Recent Employer: Amylin Pharmaceuticals, Inc.

Career Level: Manager, Director Level

Availability or Timeframe: Immediately

Authorized to work in the US: Yes

Security Clearance:

Do you have transportation: Yes

Over 18: Yes

Education: Bachelors

Languages Spoken: English, Vietnamese

Job Preferences

Desired Salary: Open

Willing to Relocate:

Desired Job Titles:

Desired Job Types: Employee

Work Status: Full Time

Desired Shifts: 1st Shift

Desired Travel:

Category: Total Quality, Sales/Business Development, Project Management, Operations,

Manufacturing/Industrial, Health Care Management, General Management and Administration,

Engineering and Research, Customer Service

Company Size:

Company Type:

Industry:

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Copyright c 1997- Lee Hecht Harrison, Inc.

Name: Deborah Moore

Address:

City: Irvine

State: CA

Zip/Postal Code: 92612

Country:

E-mail: abpsls@r.postjobfree.com

Primary Phone: 949-***-****

Background

Most Recent Job Title: Sr. Manager II Clinical Data Management

Most Recent Employer: Allergan, Inc

Career Level: Manager, Director Level

Availability or Timeframe: Within a month

Authorized to work in the US: Yes

Security Clearance:

Do you have transportation: Yes

Over 18: Yes

Education: Some College

Languages Spoken: English

Job Preferences

Desired Salary: Open

Willing to Relocate:

Desired Job Titles:

Desired Job Types: Employee

Work Status: Full Time

Desired Shifts: 1st Shift

Desired Travel: 25%

Category: Health Care Management, Operations, Other

Company Size:

Company Type:

Industry: Biotechnology, Computers Software and Hardware, Pharmaceuticals

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Reserve and LeadLink Terms of Use prohibit automated extraction of data, marketing, or

fees of any kind. Resume Reserve data is private and may only be used by authorized

individuals. Access codes for resume viewing and job lead posting are issued and owned by

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Copyright c 1997- Lee Hecht Harrison, Inc.

DEBORAH J. MOORE

3700 Parkview Lane, 22B

949-***-**** (H)

Irvine, CA 92612 949-***-**** (C)

CLINICAL DATA MANAGEMENT PROFESSIONAL

Results-oriented Senior Manager with Director level experience establishing solutions for

new and existing Clinical Data Management (CDM) departments to meet challenging business

demands for global pharmaceutical, medical device and biotechnology organizations. Proven

abilities and extremely knowledgeable of clinical trial methodologies as well as current

and emerging global data management standards, technology and worldwide regulatory

requirements. Areas of expertise include:

Strategic Planning/Implementation

Business Development Initiatives

Developing Procedures

Leadership/Team Building

Analytical Thinking and Problem Solving

Project Management

TECHNICAL SKILLS

PhaseForward Inform, Oracle Clinical v.4.5.1, DLB Systems Recorder Runtime v.3.0, DLB

Monitor v.3.0, Clintrials, Clinteams v.5.0, 5.1, SAS v.9.1, MedDRA v.7.1, 8.1, Integrated

Review, CRFTrack, Form Flow Form Designer v.2.22, Adobe PageMaker, Adobe InDesign CS4,

Macromedia Breeze, MS SharePoint, Planet, Visio, ERA Documentum, MS Office Suites (Excel,

Word, Powerpoint, Access, Project)

PROFESSIONAL EXPERIENCE:

Allergan, Inc

., Irvine, CA 20052009

Senior Manager II

Clinical Data Operations & Training (2006-2009)

Provided oversight of data operations activities (Case Report Form (CRF) design, Standard

modules, WHODrug coding, CRF Process Flow, Central Filing, Training and Development) as

well as resource management for support of therapeutic area programs (e.g., Botox,

Neurology, Ophthalmology).

Oversaw the development and implementation of new data management systems and tools

including user acceptance testing on individual study protocols.

Managed the development and implementation of Data Management & Programming (DMP)

department procedures, system training and launched new employee orientation manual.

Collaborated with Global Health Outcome department to develop process map to define their

procedures for managing and tracking country/dialect foreign language translation of

documents.

Coordinated the development of new audio training curriculums utilizing Macromedia Breeze

software resulting in department review of SOPs within two weeks to strengthen training

proficiency and ensure compliance.

Successfully supported 2008 submission timelines for studies utilizing paper CRFs (29)

and EDC (4).

Senior Manager II

Clinical Data Management (20052006)

Overall responsibility for CRF design, Chaired CRF Standards Committee, developed DMP

department training and quality control procedures. Oversight and training of UK and Asia

Pacific Data Management Liaison divisions to support global studies for all therapeutic

areas.

Allergan, Inc

., Irvine, CA (Continued)

Senior Manager II

Clinical Data Management (Continued)

Implemented global training procedures compliant with Regulatory (FDA, MHRA) and internal

requirements.

Oversight for internal and outsourced data management personnel and activities in support

of clinical research studies.

Led cross-functional CRF Standards Committee to support efficient development and

implementation of global standards, Completion Instructions and Training material to

maximize development of study related documents.

Responsible for management of DMP job descriptions, CVs and training records maintained

electronically.

Xcyte Therapies, Inc

., Seattle, WA 20012005Senior Manager, Clinical Data (2003 2005)

Created operational plans and schedules for CDM department to carry out objectives;

developed and calculated budgets for areas of responsibility to meet organizational goals;

forecast future departmental needs including human and material resources and capital

expenditures; and developed job descriptions.

Provided input into development of protocols and FDA response letters.

Developed new work processes that had broad applicability throughout the company and

impact on work processes and personnel in multiple units or departments.

Represented the organizational unit as prime internal contact on contracts and

operations; conducted briefings and technical meetings for top management and customer

representatives.

Initiated pre-analysis review team meetings to assign tasks and document decisions.

Developed and coordinated Clinical trial project timelines for regulatory submissions,

symposiums (e.g., ASH, ASCO), manuscripts, CSR, and Investigator Brochures to align

priorities and resources.

Manager, Clinical Data (2001-2003)

Analyzed CDM business needs of biotechnology company to support development of T-cell

receptor based product used in the treatment of cancer and infectious disease (e.g.,

prostate, myeloma, renal cell carcinoma and chronic lymphocytic leukemia, Non-Hodgkin s

lymphoma). Assessed and managed clinical trial projects utilizing contract research

organizations (CRO) to ensure up-to-date clinical information for President and CEO to

present during symposium, board investor presentations and regulatory bodies.

Responsible for development and oversight of all CDM activities including development of

data management plan, dataset transfer, WHODrug and MedDRA Coding, QA, and data validation

plans. Developed and conducted audit program of CRO data management providers.

Managed data analysis activities of Statisticians, SAS Programmers and CDM providers.

Collaborated with statistician to define robust statistical analysis plan template.

Coordinated CRF design process to ensure requirements of protocol, data model and

statistical analysis considerations were met.

Evaluated EDC and conventional paper CRF data management service providers to ensure

compliance with 21 CFR Part 11. Negotiated and awarded lowest cost contract with selected

vendors.

Guidant Corporation, Advanced Cardiovascular Systems, Santa Clara, CA 19962000

Manager, Clinical Data Management Systems (CDMS) (19982000)

Provided direction and guidance to meet organizational goals in the support of market

share, new product development for clinical studies, marketing evaluations and physician

preference tests. Responsible for overseeing CDMS department consisting of Study

Administration (including product accountability), Data Entry, Data Analyst, System

Analyst, CRF Design and Clinical Central Files (CCF).

Negotiated all cost effective CRA monitoring contracts with CROs to provide services for

clinical studies with budgets ranging 2.5 5 million dollars.

Created immediate to long-range plans to carry out objectives. Functioned as advisor in

the development of edit specifications, project management timelines, protocols, CRF

design, and data analysis.

Presented CDM services and CRFs at Investigator meetings or individual Site initiations.

Coordinated training activities with Clinical staff to expand department s data

management knowledge base to support new business units (e.g., Radiation, Peripheral and

Renal).

Simultaneously maintained 14 ongoing clinical trials representing 8,000 patients while

processing 7 new studies for implementation within a 90-day period for an additional 2,000

patients.

Determined resource allocation to successfully meet each request for data to be submitted

in ad-hoc reports, abstracts or to a governing body.

Monitored regulatory and guidance updates from FDA, ICH, GCP and BSi.

Collaborated with Japanese division of company in the submission of data obtained from US

trials.

Supervisor, Clinical Data (19961998)

Developed CDM department for medical device company with oversight of data processing

activities, CRF development, and CCF to support Coronary Stent, Atherectomy, Accessories,

and Guide wire business units. Coordinated activities with Minneapolis, and Brussels

divisions to develop a shared database. Worked with Information Systems (IS) to define

data model and research data items. Participated in Verification/Validation of new

versions of software.

Wrote DOPs/SOPs, and guidelines to define and standardize departmental procedures within

CDM and interaction with other departments. Peer reviewed IS documentation used to define,

validate and document systems. Provided input into protocol development.

Selected and worked with contractors to define, purchase and set-up Clinical Central

Files as a fire proof, color-coded, alphanumerical filing system. Re-engineered protocol

numbering assignment system used to identify and track studies.

Negotiated cost-effective contracts for printing of CRFs for distribution to US and OUS

sites.

Hired, trained full-time and temporary staff in the use of hardware, software and

departmental procedures. Wrote job descriptions and worked with Human Resources to

determine compensation.

Clinical Data Management Consultant, Shreveport, LA 1/1996-7/1996

Independent Consultant

Provided data management expertise and services for pharmaceutical company that included

database set-up, data entry, validation, discrepancy management, reports and project

management liaison between US regional CRA, and Clinical staff to support submission in

United Kingdom (UK).

BASF KNOLL Pharmaceutical Company, Shreveport LA 19851995

Clinical Data Coordinator

(19911995)

Supported implementation and testing of new BBN/Clintrial software for pharmaceutical

company, which was used in the development of database protocol activities including

defining data model, panels, data items, code lists and data listings.

Consulted with clinical staff, statisticians and programmers on specifications for data

edits, reports, analysis and query tracking.

Reviewed CRFs for conformity to protocol and annotated for data standardization.

Reviewed error logs for missing data, logical and relational checks to create accurate

datasets.

Supervised five data entry personnel and three data assistants.

Defined data validations, conversion procedures and retrievals. Created study specific

documentation and wrote keying instructions.

Lead project team for Central Nervous System and Cardiovascular long-term extension

studies.

Organized monthly meetings for Clinical Data Coordinators to discuss issues and promote

standardization of study setup and reports.

Senior Clinical Data Analyst

(19871990)

Planned and assigned work activities from receipt of new CRF transmittal forms, and

processing through filing within Data Management and Medical Records department.

Senior Data Entry (1985 1987)

Designed and tested data entry screens, layouts and mappings utilizing SAS and Clinteams

software. Performed quality assurance review and edited data for Phase I IV clinical

studies, and generated documentation for audit purposes. Trained new data entry personnel

in the use of hardware, software and departmental procedures.

EDUCATION

1999

Computer Systems Information classes, DeAnza College, Cupertino, CA

1974

1977 Business Administration & Marketing Southern University, Shreveport, LA

PROFESSIONAL AFFILIATIONS

Society of Clinical Data Management (SCDM)

Drug Information Association (DIA)

American Society for Training and Development (ASTD)

ACTIVITIES

SCDM volunteer committee member for review of GCDMP Guide v.3.0

Define development requirements, beta testing of EDC Systems with DLB, Inc.

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