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Jessica
Claire
resumesample@example.com
(555) 432-1000,
Montgomery Street, San Francisco, CA 94105
:
Executive Profile
Clinical Operations/Clinical Project Management executive with over 28 years of clinical trial experience. 15 years of experience managing full service and functional service CROs and vendors both domestically and internationally (including North America, Latin America, Western Europe, Eastern Europe and India). Extensive experience managing vendors providing the following services: IVRS/IWRS, data management, clinical supplies, monitoring, site recruitment, site selection, site qualification, site management, site close out, project management, subject enrollment, statistics, budget and contract creation, negotiation and management, investigator meetings, medical writing, tactical and strategic regulatory all both domestically and internationally. 10 years of experience working in CROs (PharmaKinetics, Pharmaco [now PPD] and Quintiles) as both a CRA (2 years) and project manager/project director (8 years). 15 years of experience managing clinical operations teams in sponsor companies. Departments managed - clinical monitoring, clinical project management, clinical administration, phase I operations, statistics, data management, medical writing, budgets and contracts, outsourcing, clinical systems (processes, SOPs and training) and document management. Over 20 years successful personnel management/mentoring experience (Manager, Associate Director, Director and Senior Director) Created the clinical operations function at both Texas Biotechnology Corporation and KV Pharmaceutical Company. At KV, took company's first branded drug from formulation development complete to NDA filed in 26 months Clindesse approved in 2004 Negotiated the successful clinical development program for the Clindesse product for bacterial vaginosis and presented at the Pre-NDA meeting. Responsible for the successful clinical development program (clinical pharmacology, Phase II and Phase III) for Argatroban (a thrombin inhibitor) at Texas Biotechnology Corporation which resulted in approval in 2000. Extensive budget and contracting experience - peak departmental budget of over $50 million Attended 8 FDA meetings and presented at FDA on several occasions. Extensive IND development and support experience. Expert level ICH/GCP knowledge Solid record of progression in responsibility at each previous company
Skill Highlights
  • Project management
  • Leadership/communication skills
  • Product development
  • New product delivery

  • Global and strategic sourcing
  • Budgeting and forecasting
  • Process improvement
  • Unsurpassed work ethic

Education
Lamar University Beaumont, Texas Expected in 1988 BS : Biology - GPA :
, Expected in Certified Project Management Professional (PMP), August, 2000, Project Management Institute : - GPA :
Core Accomplishments
  • Project Management:
  • Initiated Clindesse Bacterial Vaginosis development program which resulted in NDA filing in 26 months.
  • Created Clinical Operations Function at KV Pharmaceutical Company from 1 employee to a peak of 42 employees
  • PMP Certification
  • Extensive sponsor management experience at Pharmakinetics, Pharmaco and Quintiles
  • Extensive record of promotion and progression at each company
  • Six Sigma Greenbelt Certified
Experience
Dexcom, Inc. - Senior Director, Clinical Affairs
Chicago, IL, 07/2001 - 08/2012

Develop and coordinate clinical research programs designed to support the KV effort to obtain approved New Drug applications and Abbreviated New Drug Applications for various therapeutic entities in sustained release dosage forms and conventional dosage forms. Provide clinical research support for company marketing/sales efforts and other corporate projects as required. Develop and implement Phase I, II, III and IV clinical protocols/studies in a variety of therapeutic areas. Provide required input for IND, NDA, ANDA and routine FDA submissions. Coordinate all clinical research activities within KV Pharmaceutical Company. Develop and maintain clinical research SOPs. Prepare and manage departmental budget.

Kion Group - Senior Director, Project Management
Columbus, OH, 01/1998 - 05/2001

Direct, supervise and develop Project Managers and/or Project Directors, providing scientific support and operational advice as and when needed. To take responsibility for the commercial and technical success of all projects under the direction of the Sr. Director. To ensure Customer satisfaction for all projects responsible. To work with Business Development to ensure the development and growth of new business. Develop Training programs to maximize the potential of all project managers/directors in the business unit. Continuously review project tracking tools to ensure they are providing adequate information for the Oncology Business to understand the status of projects under the direction of the Senior Project Director.

Pbk Architects - Director, Clinical Operations and Administration
Costa Mesa, CA, 01/1994 - 01/1998

Overall responsibility for project management, monitoring and administration of all clinical trials conducted by Texas Biotechnology Corporation. Duties include: supervision of all operational aspects of clinical trial programs, all planning and administration functions within the Clinical Development and Regulatory Affairs Division including financial management, resource management, project planning and general administration. Supervised a team of 2 project managers, 6 clinical research associates, 1 administrative manager and 2 administrative assistants. The team had responsibility for 3 drugs in Phase I through Phase III clinical development. Also responsible for development, tracking and adherence to Clinical Development and Regulatory Affairs Division budget.

Endologix - Senior Project Manager
Boston, MA, 08/1991 - 03/1994

Responsible for all aspects of the management of single and multicenter clinical research studies. Responsibilities included: sponsor liaison, protocol development, case report form development, study planning, timeline generation and maintenance, site recruitment, investigator meeting planning, oversight of study progress including contractual and fiscal obligations or research studies, IND preparation and study report generation. Also responsible for the management of teams of less senior Project Managers, Clinical Research Associates, Data Managers, Medical Writers and Clerical personnel. Responsible for direct line supervision of four project manager direct reports and five clerical staff direct reports. During my tenure at Pharmaco LSR, I managed projects encompassing 24 different clinical studies in three different therapeutic areas with combined overall budgets of approximately $ 21 million

Bioclinica, Inc - Clinical Research Associate
Newark, CA, 03/1990 - 08/1991

Responsible for all aspects of monitoring 7 sites encompassing two protocols to evaluate a novel antidepressant. Assigned to team responsible for preparation and submission of an NDA for a new tricyclic antidepressant. Wrote three protocols and one final study report.

Endologix - Assistant Clinical Project Manager
Orlando, FL, 08/1989 - 03/1990

Responsible for the management of three domestic and one foreign multicenter clinical trial involving 70 domestic and 10 foreign investigators and a total of 2800 patients. Responsibilities included assisting in the preparation of protocols and case report forms, preparation of weekly and monthly progress reports, investigator recruitment, timeline preparation and maintenance, supervision and training of CRAs, project expense accounting, negotiation and management of investigator budgets and liaison with investigators, project sponsor and project vendors.

Pharmakinetics Laboratories Inc - Clinical Research Associate
City, STATE, 10/1988 - 08/1989

Responsible for all aspects of monitoring 8 sites encompassing two protocols. Monitoring duties included monthly site visits, grant disbursement, monthly reporting, adverse event monitoring and drug accountability. Conducted investigator recruitment and qualification, study initiation, monthly monitoring and study close-out. Assisted in protocol and case report form development and NDA compilation and submission.

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Resume Overview

School Attended

  • Lamar University

Job Titles Held:

  • Senior Director, Clinical Affairs
  • Senior Director, Project Management
  • Director, Clinical Operations and Administration
  • Senior Project Manager
  • Clinical Research Associate
  • Assistant Clinical Project Manager
  • Clinical Research Associate

Degrees

  • BS
  • Certified Project Management Professional (PMP), August, 2000, Project Management Institute

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