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Head, Clinical Protocol Management Services Resume Example

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HEAD, CLINICAL PROTOCOL MANAGEMENT SERVICES
Summary

Experienced Senior Operations/Project Manager possessing comprehensive knowledge of project and program management techniques. Natural leader driven to motivate teams to exceed business goals and targets while under pressure. Assertive and enthusiastic, with more than 15 years of management experience and extensive knowledge of the Clinical Trials industry.

Highlights
  • New Business Development
  • Procedure development
  • Process improvement strategies
  • Contract management
  • Systems implementation
  • Relationship building
  • Client relationships
  • Staff development
  • Vendor sourcing
  • Purchasing and procurement
Experience
Head, Clinical Protocol Management ServicesJan 2008 to Nov 2013
Sonic Clinical Trials Pty Limited － Sydney, Australia

  • Project Management: Defined project deliverables and monitored status of tasks.Drafted action plans and led meetings with department executives to review project status and proposed changes. Collaborated with cross-functional teams to draft project schedules and plans. Updated and managed project databases.
  • Business Development: Negotiated rates to cut costs and benefit corporate partnerships. Identified, coordinated and participated in client relationship-building activities and meetings.Tracked RFPs and bids to develop new business opportunities.
  • Client Support Services: Developed, implemented and monitored programs to maximize customer satisfaction and manage on-site customer service representatives.Interviewed, hired and trained new quality customer service representatives. Developed and implemented policies, procedures and process improvement initiatives to improve retention rates and increase customer satisfaction.
  • Logistics: Negotiated contracts with outside providers to minimize costs to the company and customers. Forwarded client-related quality and service issues to the appropriate manager for resolution and CAPA reporting. Hosted monthly KPI and metrics review meetings with vendors to ensure optimal service delivery.
  • Production: Reviewed production orders, schedules, delivery dates and inventory levels to determine product availability.
  • Trained, developed and counseled employees to develop a high performing team.
  • Budgeted monthly departmental expenses and implemented cost controls.
  • Provided detailed monthly departmental reports and updates to senior management.

ACHIEVEMENTS:Instrumental in the establishment of newly formed business venture Sonic Clinical Trials Pty. Ltd. Successfully completed the development of a fully validated Clinical Trials Management System along with an accredited central laboratory with supporting operations facilities and SOP's. Achieved projected business plan goals within expected time lines in order to turn Sonic Clinical Trials into a successful and profitable division of Sonic Healthcare which is now servicing the pharmaceutical and biotech industries running clinical trials in the Asia-Pacific region. 

Operations ManagerJan 1998 to Dec 2007
Sonic Clinical Trials Pty Limited/Covance CLS － Sydney, Australia
  • Project set up and management: Senior manager for projects at Sonic Clinical Trials in collaboration with the Global Project Manager assigned by Covance CLS. Providing presentations at Investigator Meetings and site training sessions.
  • Recruited, hired and trained up to 25 new employees for Operations and Kit Production and Logistics.
  • Management and training of Operations department personnel.
  • Identify process and efficiency improvements and implement solutions.
  • Kit Production facility management including inventory management and logistics.
  • Earned Covance Way Award for increasing productivity and efficiencies during 100% growth period for the region.

ACHIEVEMENTS:Regional coordination and management of over 800 clinical studies in Australia, New Zealand and Asia Pacific spanning over 12 years. Studies spanned over 20 different therapeutic areas and serviced over 2000 regional investigator site locations. Effectively built a strong operations/customer support team and production facility. Laboratory for Covance CLS Singapore was established in 2000. Provided support and training of new Covance CLS personnel in all client support and sample management departments. 

Operations Supervisor and Laboratory ScientistJan 1996 to Jan 1998
Sonic Clinical Trials / Covance CLS － Sydney, Australia

ACHIEVEMENTS:Founding member of the Sonic Clinical Trials division of Douglass Hanly Moir Pathology under exclusive contract to Covance Central Laboratory Services Inc. Received training at international Covance Europe and US locations as well as on site in Sydney. Training was given in all necessary lab and operational functions required to support the central laboratory services in the region for Covance CLS. 

Work History
Scientific Officer / Medical ScientistJan 1992 to Jan 1996
Douglass Hanly Moir Pathology － Sydney, Australia
Night Supervisor / Laboratory AssistantJan 1989 to Jan1992
Southwest Diagnostics Pathology － Sydney, Australia
Education
Bachelor of Science, Medical Laboratory ScienceCharles Sturt University － NSW, Australia
Diploma Applied Science, NursingCatholic College of Education － NSW, Australia
Professional Courses and Certifications
Certification, IATA Dangerous Goods AwarenessSydney, NSW, Australia
Training, Emotional IntelligenceSydney, NSW, Australia
Training, Leadership in Action WorkshopSydney, NSW, Australia
Training, Conflict Management and ResolutionSydney, NSW, Australia
Training, Good Clinical PracticesSydney, NSW, Australia
Training, People Management ProgramSydney, NSW, Australia
Training, FDA 21 Part 11 and Data IntegritySydney, NSW, Australia
Cross Cultural Training, Doing Business With JapanSydney, NSW, Australia
Course, Labware LIMS Administrator 1Sydney, NSW, Australia
Course, Computer Systems ValidationSydney, NSW, Australia
Skills

Operations Start-Up, Organizational Skills, Project Management, Team Building and Leadership, Business Development, Departmental Operations Management, Staff Training and Development, Vendor and Contract Negotiations, Customer Relations, Quality Management, Logistics, Communication Skills, Workflow Planning, Time Management, Biological Samples Transportation Logistics, IATA Dangerous Goods, Systems User Requirement Specifications, Systems Validation

Professional Affiliations

ARCS Australia - Association Regulatory and Clinical Scientists

DIA - Drug Information Association

Clinical Partnerships Asia

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Resume Overview

Companies Worked For:

  • Sonic Clinical Trials Pty Limited
  • Sonic Clinical Trials Pty Limited/Covance CLS
  • Sonic Clinical Trials / Covance CLS
  • Douglass Hanly Moir Pathology
  • Southwest Diagnostics Pathology

School Attended

  • Charles Sturt University
  • Catholic College of Education

Job Titles Held:

  • Head, Clinical Protocol Management Services
  • Operations Manager
  • Operations Supervisor and Laboratory Scientist
  • Scientific Officer / Medical Scientist
  • Night Supervisor / Laboratory Assistant

Degrees

  • Bachelor of Science , Medical Laboratory Science
    Diploma Applied Science , Nursing
    Certification , IATA Dangerous Goods Awareness
    Training , Emotional Intelligence
    Training , Leadership in Action Workshop
    Training , Conflict Management and Resolution
    Training , Good Clinical Practices
    Training , People Management Program
    Training , FDA 21 Part 11 and Data Integrity
    Cross Cultural Training , Doing Business With Japan
    Course , Labware LIMS Administrator 1
    Course , Computer Systems Validation

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