Project Manager Management

KHIN NU

Shoreline, WA Cell: 206-***-**** ********@*****.***

OBJECTIVE

Seek a Full Time Clinical Research Professional Position in Pharmaceutical Industry.

HIGHLIGHTED QUALIFICATIONS

Over 12 years of combined academic and biotech experience in clinical trials (US and Global)

Strong knowledge of protocol and clinical drug development processes, clinical study design,

study plan, train, manage, monitor and close out to achieve accurate and timely results.

Proven project management, trial management and study leadership capabilities.

Strong experience in CRO management (Covance, Chiltern, Quintile, Kendle)

Strong experience in Vendor management (WorldCare Clinical, LLC, MDS Pharma Services,

Chesapeake IRB, DF Net Data Management)

Strong experience in Data review and management to ensure quality and consistency (DF Net,

Quintiles)

Strong experience in timeline development and management (Press Releases, Data Locks, CSRs).

Strong experience in Budget management (CROs & Vendors)

Strong experience in Safety and Pharmacovigilence management (MedWatch, SUSARs)

Experience with Phase I-IV trials in the following areas: Pandemic Influenza Vaccine with

Infectious Disease Research Institute (IDRI), Oncology with Cell Therapeutics (CTI) and

Hematology, Transplantation, Virology and Noble Microbes including Vaccine Trials under

Program in Infectious Diseases, Fred Hutchinson Cancer Research Center (FHCRC) and

University of Washington (UW).

Provide clinical operations expertise to produce clinical trial deliverables including study

protocols, study procedures manuals, case report forms, informed consent forms, clinical study

agreements, clinical study reports, and all other documentation necessary for study conduct.

Work in compliance with regulatory requirements, ICH/GCP guidelines, and SOPs.

Maintain collaborative relationship with cross-functional teams to lead management of clinical

operations.

Review, negotiate, and implement clinical budgets, agreements, contracts, accrual, and payment

approvals.

Manage full scope of study documents (CTMF) and ensure that documentation from investigators

and investigational sites meets FDA/GCP/ICH requirements for retention and submission.

Experience in NDA submission and FDA audit and EMEA for EU submission.

Strong interpersonal, negotiation and computer skills.

Ability to analyze and solve problems with minimal supervision and have a high attention to

detail.

Great communication, organizational, writing, presentation and leadership skills with experience

in working independently as a valued professional team member who meets project timelines,

budgets and company’s mission and vision.

Able to travel up to 30%

EDUCATION

Biotech Project Management Certificate, University of WA, USA 2011

Master of Public Health (MPH), University of Washington, USA 2005

Clinical Trials Management Certificate, University of Washington, USA 2003

Southeast Asian Studies (BA), University of Washington, USA 1999

Institute Medicine (1), Rangoon, BURMA (completed Final Part I) 1991

PROFESSIONAL EXPERIENCE

Clinical Trial Manager (July 2012 – December 2013)

INFECTIOUS DISEASE RESEARCH INSTITUTE (IDRI) Seattle, Washington

Oversee and manage a Phase I Pandemic Influenza study with (3) sites in US (Dallas, Daytona Beach,

Madison).

o Lead day-to-day operations

o Manage IDRI Consultant CRAs for (3) sites

o Review, approve Monitoring Reports and manage study CTMF.

o Provide oversight and direction to team members and vendors for study deliverables on time and

within budget

o Liaise with other functional areas

o Conduct study initiation visits and co-monitoring visits as needed (10% travel)

o Oversee clinical aspects of timely data cleaning, data analysis and the availability of top line

results (Vendor: DF Net)

o Implement appropriate systems, standards and processes to ensure quality and compliance

o Provide regular study updates to all stakeholders

o Manage payment approvals and track the budget for CRO (Covance) and other vendors

o Create and support in the preparation of effective presentations

Perform other duties as assigned

o Participate in CRO and other vendor selection for new study (117),

o Review budget and payment of other trial (Tacoma 111).

o Create and compile Vendor, CRO, PIs, and Regulatory Contact Information for IDRI Clinical

Operations (Global).

o Create CTMF set up of all IDRI Clinical Operations Trials (Global).

o Support Finance and Legal to compile Grants and Budgets Information for IDRI.

o Ensure Clinical controlled documents are updated so that trials are conducted in compliance with

the respective investigational plan and all applicable regulations, IRB requirements, and corporate

policies, procedures and strategies.

Clinical Research Associate (September 2007 – May 2011)

CELL THERAPEUTICS INC., Seattle, Washington (Global Phase II & Phase III studies)

Manage directed timelines and budget and budget forecasting with Clinical Project Manager for

Study product Pixantrone (Pixuvri).

Manage and co-monitor U.S sites (Global Phase III study) to meet corporate timelines.

Develop study tools for monitoring, tracking, process evaluation and close out evaluation.

Manage and coordinate sites in Western Europe (Chiltern is CRO) and India (Quintiles India is CRO)

as a protocol lead (Global Phase III) and support trial management for CRO (Kendle International for

Global Phase II).

Manage and coordinate below vendors to meet corporate timelines: WorldCare Clinical, LLC (A

ProScan Imaging Company), MDS Pharma Services (Central Lab), Chesapeake (Central IRB).

Review and approved monitoring reports for Western EU (Chiltern) and India (Quintiles)

Review Regulatory Documents for site close outs.

Review CTMF for Trial Close Outs.

Support CTM and Clinical Data Management for Data Reviews and Queries.

Review and assist in writing CSRs.

Review all study related AEs and SAEs (Protocol Deviations)

Review and track different versions of CRFs.

Track protocol accruals, missed visits, approved for sites and vendor payments.

Review Screen Failures for eCRFs for PIX306 start up.

International Research Project Manager 2007 (Jan-September)

Breast Health Global Initiative (BHGI)

FRED HUTCHINSON CANCER RESEARCH CENTER, Seattle, WA

Manage International Research Program involving Call for the Letter of Intent, Request for Proposals,

Review and Selection of projects/sites within budget; Project feasibility based on regions;

development of budget and processes tailored for each country (Romania, Columbia, Malaysia, and

Turkey)

Manage and coordinate Microsoft SharePoint user site for all BHGI members including Steering

Committee, Advisory Board, Project PIs and staff, Advocacy groups.

Research Coordinator II 2001 – 2007 (Program Monitor/Coordinator for Clinical Research Division,

Programs in Infectious Disease for FHCRC)

UNIVERSITY OF WASHINGTON, Seattle, WA (Virology Division)

Oversee regulatory management as outlined by protocol objectives

Review design of protocols in preparation of research protocol submission to multiple institutional

offices and draft study related documents as appropriate (i.e., ICF)

Maintain and submit required regulatory documents for clinical trials (such as FDA Forms 1571 and

1572, Investigator Brochures, Financial Disclosures, IND Safety Reports, etc.)

Maintain and audit study specific regulatory files per FDA guidelines for the Program.

Responsible for on time IRB submissions of protocols, AEs, amendments required for the Program.

References will be provided upon request.

Contact this candidate