Kathryn Britch

Email: abo5oa@r.postjobfree.com

Address: ***** ******* ******

City: Mission Viejo

State: CA

Zip: 92691

Country: USA

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

Skill Level: Management

Salary Range: 160

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Kathryn D. Britch

24542 Spartan Street

Mission Viejo, CA 92691

949-***-****

abo5oa@r.postjobfree.com

Relevant Experience

Over 21 years of experience working in the clinical research industry

Experience working in both pharmaceutical and CRO industry; US and Global experience with complex projects

Self-starter with high achievement drive; ability to surpass expectations with minimal supervision

Familiarity with IND and NDA submissions

Extensive knowledge of ICH/GCP guidelines

Development of overall clinical project plan for CNS migraine program (Phase II - IV, protocol synopses, potential drug interaction studies, special populations, abuse; budgetary forecasts, and required timelines in preparation for submission of the NDA)

Excellent Communication Skills that are Clear, Concise and Influential, Commercial Awareness, Robust Thinking, Proactive Leadership, Building Relationships, Responsiveness, Maintaining Quality Standards, Energizing and Developing Personnel

Commitment to Company and Performance

Functioned in a high profile role within the organization, maintaining in a positive manner while providing constructive input as deemed appropriate

Maintained low turnover of personnel

Advanced individual and team development skills

Actively participated in company acquisitions

Provided positive governance to effectively manage the activities of Clinical Operations and supervise staff (multiple locations and or regions) in a manner that ensured all milestones and quality targets were met and that costs were kept in line with contractual obligations

Experience with complex operations, supervising diverse teams and managing challenging programs/assignments simultaneously in a variety of areas of responsibilities

Established criteria and tracking templates that targeted the promotion of qualified Lead CRAs to a PM role (e.g. exposure to managerial tasks, experience with personnel issues, contractual and financial proficiency, etc.)

Review of all direct report Audit findings (internal and external, major and minor findings); proactive steps taken to address issues, implement changes and follow-up as needed

Development of transitions plans that ensured a smooth, minimal disruption from other CROs to ICON

Prepared increasingly more complex project specific proposals, timelines and budgets for potential new business opportunities that targeted specifics of the RFI (epidemiology, country distribution, enrollment timelines, strategies, and contingency planning)

Clinical training as a presenter/facilitator; assisted with management training company wide to improve effectiveness of the organization

Professional Experience

ICON Clinical Research

Irvine, CA

Senior Director,

Clinical Operations

April 2006 to Feb 2011

Director,

Clinical Operations

Feb 2003 to Mar 2006

Associate Director,

Clinical Operations

Aug 1999 to Jan 2003

Recruited by Clinical and Data Management Vice Presidents to oversee the start-up of a Clinical Research Department in the Southern California office (set-up, hiring, orientation, etc.)

In addition to activities of Associate and Director role noted below:

Conducted review of multiple department SOPs (gap analysis and identification of revisions in conjunction with ICH Guidelines)

Prepared increasingly more complex project specific proposals, timelines and budgets for potential new business opportunities that targeted specifics of the RFI (epidemiology, country distribution, enrollment timelines, strategies, and contingency planning)

Facilitated resolution (within ICON and with clients) of study issues, particularly critical issued impeding study progress

Initiated and/or lead multiple company/departmental initiatives

Actively participated in a company potential acquisition of a Recruitment Specialist Company

In addition to activities of Associate Director role noted below:

Initiated utilization of the Oracle(R) Clinical query component

Acted as a therapeutic specialist and strategist in preparation of proposals, timelines and budgets for potential new business opportunities (epidemiology, country distribution, enrollment timelines, strategies, and contingency planning)

Actively participated in the implementation of tools that would more efficiently track study progress to be used by the entire clinical team

Director of west coast clinical operations

Maintained local clinical staff turnover rates of

Managed the activities of the Irvine office (up to 150 personnel)

Actively participated in a company acquisition of CRO that provided extensive statistical analysis support

Collaborated with multiple departments to ensure all activities were appropriately delegated and managed

Demonstrated development, motivation and mentorship of Project Managers in multiple regions to ensure all timelines, milestones, and project budgets met or exceeded client expectations

Oversight of projects for direct reports to ensure projects were managed in accordance with the appropriate regulations, quality standards and client requirements

Acted as senior level liaison with clients

Provided financial oversight to projects to ensure appropriate profitability

Tracked, assessed and managed departmental metrics

Liaised with other managers/directors to improve the effectiveness of the organization

Preparations and implementation of on-site monitoring SOPs

Actively prepared and conducted performance appraisals that highlighted core competencies, achievements, and continued expectations

Preparation and implementation of revised job descriptions

Actively participated in the recruitment and selection of qualified staff (multiple departments)

CoCensys, Inc.

Irvine, CA

Assistant Director,

Clinical Development

Mar 1997 to Jun 1999

Recruited by the CEO to direct the CNS Migraine Program

Implementation, management and completion of clinical studies required for the submission of a NDA; assisted with the preparation of an IND; preparation of clinical protocols, ICFs, CRFs, IDBs, annual reports, final clinical study reports, clinical development plans, and project specific guidelines; assisted in the design of data management plans

Participated in company project team meetings as primary Clinical Operations Liaison

Accomplished accelerated project timelines and budgetary forecasts in the completion of two large Phase II clinical studies; established project milestones, assessed and developed contingency plans to ensure clinical projects remained on schedule and internal development team goals were met

Coordinated study responsibilities of in-house staff, CROs, and consultants in the completion of all required clinical tasks and various data management tasks; identified and supervised budgetary and resource needs; clinical liaison to all company departments; ensured the integrity of the project database was maintained

Prepared abbreviated study reports

Prepared and presented abstracts, presentations and posters for scientific meetings

Recruitment and selection of qualified staff (multiple departments); managed training and career development of direct reports

Therapeutic Experience

Cardiovascular

Angina

Congestive Heart Failure

Endocrine/Metabolic

Diabetes Mellitus

Non-diabetes Type II

Gastrointestinal

Crohn`s Disease

Infectious Diseases

Hepatitis Non-A, Non-B/C

California State University at Fullerton

Major: Physical Education; concentration Sports Medicine and Health

Graduated with Honors

Degree: Bachelor of Science

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