Project Manager Quality Assurance

VICKI CLAUSON 760-***-****

**** *** ***** ***** abncx3@r.postjobfree.com

Cardiff by-the-Sea, CA. 92007

RELEVANT PROFESSIONAL EXPERIENCE

Chiltern International, Inc., San Diego, CA Hyponatremia, Macular

Degeneration,

Smoking Cessation,

Rheumatoid

Arthritis

Global Project Manager 8/06- 10/09

Responsible for the management of global clinical studies. Ensured

consistency, quality and customer satisfaction with Chiltern Project

Management and study team. Clinical studies include: A Phase IIIb global

RA study, ~70 sites in 3 countries with 335 subjects and an extension

protocol involving the same subjects; .a Phase III trial with 65 sites in

14 countries (NA & EU), 800 subjects; a Phase II study with 6 sites and 150

subjects; a Phase II study with 52 sites and 450 subjects. Project teams

consisted of project managers (US and Europe), Lead CRAs and administrative

staff members. Acted as the main liaison between the Sponsor and all

Chiltern functional departments associated with the projects including,

data management, biostatistics, medical affairs, quality assurance and

regulatory affairs. Key areas of responsibility include:

. Oversee and coordinate project teams conducting domestic and

international clinical trials

. Responsible for conducting studies within timelines and budget

. Design, communicate and implement project plans

. Establish timelines and monitor project goals and objectives

. Coordinate internal multidisciplinary teams to ensure both timeliness and

accuracy of studies

. Negotiate study budgets

. Responsible for the overall management of all aspects of the project

including monitoring, data management, statistics and medical writing.

. Develop in conjunction with sponsor budgets and timelines.

. Develop project tracking tools for subject enrollment, site payments,

client invoicing, site visits, etc.

. Oversee the development and review case report forms, CRF guides,

monitoring plans, and project team plans

. Identify and select investigators

. Oversee the collection and review of critical study documents

. Supervise monitoring and support staff on project teams

. Initiate and conduct periodic team meetings and/or conference calls to

discuss the progress of the project

. Oversee all regulatory and IRB applications, including timelines,

awareness of and adherence to regulatory guidelines

. Present at investigator meetings

. Review all relevant project related documents

. Ensure quality control of CRA visits and verify that CRAs work to study

guidelines and project timelines

PRACS Dermatology, Poway, CA.

Associate Director 4/06- 8/06

Managed 2 project managers, 2 CRAs and 3 project assistants. Responsible

for all departmental policies and processes; review study related documents

and act as liaison with other company personnel. Attend all client meetings

and act as the contact person for all escalation plans. Revise and

implement departmental SOPs and processes.

Sr. Project Manager 7/05- 4/06 Cold Sores, Wound Healing, Impetigo

Managed 3 clinical studies with 3 Sponsors. Including an international

study in Central, South and North America. Each of the studies was full

service including data management, regulatory affairs, biostatistics,

medical safety and medical writing. Responsible for vendor selection and

contract negotiations of vendors to label, package and ship the product,

central laboratories, central IRBs, printers and a contract CRAs.

Clinimetrics, San Diego, CA. Dental Implant, Psoriasis

Sr. Program Manager 8/04- 7/05

Managed a dental implant program consisting of 3 studies; an IDE study, a

pre-IDE study and a marketing study. Each of the studies was full service

including data management, regulatory affairs, biostatistics, medical

safety, medical writing, clinical and administrative staff.

PPD Development, San Diego, CA. CNS, HIV, Vaccine - Drug/Biologics

Sr. Project Manager 6/02- 7/04

Managed clinical studies. A Phase III global vaccine study, with ~195 sites

in 4 countries; a Phase IV vaccine trial with 12 US sites; a Phase III

alcohol abuse trial with 24 sites in the US and 627 subjects, and an

extension protocol involving the same subjects. Project teams consisted of

project managers (US, Europe and South America), Associate PMs, CRAs and

administrative staff members. Line manager for the CRAs. Acted as the main

liaison between the Sponsor and all PPD functional departments associated

with the projects including, data management, biostatistics,

pharmacovigilance, quality assurance and regulatory affairs.

VivoMetrics, Inc., Ventura, CA. Sleep Apnea - Medical Device

Director, Clinical Services 7/01- 6/02

. Develop and implement clinical protocols for Non-Significant Risk

studies

. Act as Liaison between the Product Development department and

external customers

. Developed all SOPs for the department

. Established the Customer Service Department

HemoTherapies, Inc., San Diego, CA. Liver Dialysis - Medical Device

Director, Clinical Research & Regulatory Affairs 1/00 - 7/01

. Responsible for the RA/QA/CR and Data Analysis Departments

. Staff of 2 full-time employees and 2 consultants

. Reviewed all documents, training manuals, educational materials &

web site contents for regulatory adherence

. Managed the QA department; acted as management representative to

relay the quality status to executive management

. Manage the Clinical Data Department with responsibilities for

commercial and study data

. Perform customer complaint analysis and trending; including MDR

reporting

. Develop and maintain departmental SOPs and all study related files

and documentation

CCS Associates, Mountain View, CA. ChemoPrevention - Drugs

CRA Manager 5/97 - 1/00

. Managed the daily activities for a staff of 5-8 CRAs and

assistants who managed 45 active clinical trials

. Hired and trained new employees; developed the CRA training

program; performed employee evaluations

. Maintained databases which tracked the progress of each trial,

personnel site visits and activities

. Developed the SAE reporting and tracking system

. Developed and tracked on-site monitoring plans to meet Sponsor

obligations

. Developed proposals for new contracts including timelines and

budgets

. Tracked and monitored all contractual obligations with Sponsors

. Acted as the main liaison between clients and the company

. Organized and hosted weekly meetings to review the status of each

study with the appropriate personnel

. Presented at Investigator meetings and Sponsor audits

. Developed and revised SOPs and guidelines

Medtronic Interventional Vascular, San Diego, CA. Cardiac - Medical

Devices

Clinical Specialist 8/95 - 5/97

. Responsible for providing clinical support on product development teams

. Conducted animal studies (GLP & non-GLP), and physician assessment

studies both USA and non-USA

. Wrote protocols & final reports, developed CRF's, recorded & analyzed

data for all preclinical animal studies

. Wrote protocol and developed the CRF for the next generation stent PMA

clinical study

. Developed a Clinical Manual outlining company policy and ethics for

Investigator information

. Worked with consultants and managed personnel from a CRO in a PMA project

Dura Pharmaceuticals, San Diego, CA. Asthma - Drugs

Clinical Research Associate 1/94 - 8/95

. Performed study initiation, training, monitoring and close-out visits

. Managed a CRO; Audited the CRO

. Designed labels for open and double-blind studies; Developed the in-house

labeling process

Intelligent Surgical Lasers, Inc., San Diego, CA.

Ophthalmology - Medical Device

Project Manager 2/92 - 1/94

. Responsible for the Quality Assurance and Research, Pre-clinical and

Clinical

. Organized and led the hands-on demonstrations of all wet-labs conducted

during Ophthalmic meetings, at private seminars and in-house using

enucleated eyes

. Conducted clinical trials with the laser both domestically and

internationally

. Trained physicians and staff in using the laser and positioning patients

Kabi Pharmacia Ophthalmics, Inc. Monrovia, CA. Ophthalmology-Medical

Device

Clinical Research Associate 1/90 - 2/92

. Responsible for conducting Phase I, II and III clinical trials with Class

III medical devices

. Wrote clinical protocols and created CRFs

. Performed site initiation, monitoring and close-out visits in compliance

with FDA regulations and GCPs

. Assisted in preparing the clinical sections of FDA submissions (IDE's,

510K's, PMA's)

. Worked closely with the Regulatory Department in assuring compliance of

study materials and study conduct

Quality Systems Supervisor 10/86 - 1/90

International Medication Systems, Ltd., S. El Monte, CA. Parenterals -

Drugs

Supervisor of New Product Development/Biologist 8/84 -10/86

EDUCATION

Bachelor of Science degree in Biology, Southeast Missouri State University;

Cape Girardeau, MO.; 1983

Associate of Applied Science degree in Animal Health Technology, Jefferson

College; Hillsboro, MO.; 1980

PROFESSIONAL ORGANIZATIONS

Society of Clinical Research Associates - CCRA Certification 11/98

Association of Clinical Research Professionals

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