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Lead Clinical Research Associate Resume Example

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LEAD CLINICAL RESEARCH ASSOCIATE
Executive Profile
Preparing, maintaining and implementing action plans Mitigation and contingency plans Ensure cross-functional awareness and buy-in to the risk/opportunities action plans Influence Strategy and Ensure Operational Alignment Lead or contribute to Development of Strategic Clinical Operations Plan Translate development plan goals into tangible relevant goals for studies Partner with PMs and study team members to develop study level plans and goals and ensure alignment with overall development plan. Propose alternative study operation strategies to optimize use of time cost and resource Maintain and enhance knowledge in disease and technical areas and in global regulations/guidelines pertaining to clinical trials Manage Information & Communications Provide high quality study information to support decision making Ensure effective communication across study teams, removing barriers when necessary Ensure study team and stakeholders and informed of progress against goals, major study risks/opportunities and corresponding contingency/mitigation plans Ensure issue escalation and appropriate resolution Demonstrated knowledge of clinical development and regulatory submission processes and requirements Demonstrated ability to manage complex projects and processes Proven track record of effective project management of drug development or other projects in a highly matrixed environment. Required to deliver, time, and cost, quality and risk management to teams. Understands and has demonstrated ability to manage large and complex budget; history of staying on or under budget Makes strategic use of business data to monitor & raise performance Provides timely feedback to individuals/supervisors regarding performance Utilizes and encourages and shares innovative approaches to build and maintain a competitive advantage Respectfully challenges practices, decisions or ideas to uphold integrity and ethical standards Develops a learning organization, encouraging experimentation, risk-taking, and development in all aspects of work performance Responds to changing situations and others' ideas that differ from own positively and constructively Develops and implements short-term and mid-term goals and project plans to achieve goals based on higher level business drivers and strategies; eliminates obstacles to success Analyzes and solves problems to make effective decisions Consistently takes and encourages actions that are new, or that improve existing approaches and systems Having the personal and organizational confidence to communicate difficult messages promptly and in a suitable manner so that appropriate actions can be taken. Encourages contributions by generating commitment to and achievement of business objectives; serves as an advocate for others Lobbies key internal and external stakeholders to ensure success Looks for opportunities for collaboration and acts upon them Work with others to ensure close collaboration and support Works collaboratively with group members and contributes to positive intra- and inter-team relationships Demonstrated ability to manage a variety of personnel in a highly matrixed environment. Transparent skills in providing vision, direction and leadership to a group of individuals Drives and encourages conversations and proposals within Teams and between Lines that provide options to deliver the key decision points faster and more cost effectively with respect to the execution of the plan (e.g. pushing the limits of team effectiveness).
Professional Experience
Lead Clinical Research Associate
May 1998 to 31
Danaher
Assistant Scientist
January 1994 to 15
The Director
  • Clinical Programs, using project management and leadership skills, is responsible for the delivery of one or more clinical studies from study concept through reporting, submission and as needed regulatory defense activities in alignment with the overall program timeline, to cost and quality goals through the matrix leadership of the Study Team(s).
  • Accountable for strategic oversight, study delivery and plays an important role in facilitating alignment and synergy across multiple studies in larger programs.
  • Champion operational excellence to provide continuous improvement of processes and sharing of best practices.
  • Co-Chair Joint Leadership Team Meeting - Pharma, Surgical and VC Operations Lead Operational Delivery at the Program Level Team Leadership Establish and charter the team through interaction with ClinOps and partner lines Lead the study team in achieving time, cost, quality goals & milestones Develop and maintain positive team dynamics Facilitation and effective decision making Lead dev.
Director
Terracon
  • Program Study Manager (PSM) 01-Aug-2009 - 15-Apr-2011 Global Clinical Trial Management, Development Operations Promoted to director based on prior work as PSM as well asCPM and ICT PM roles Manage and ensure high quality, timeline driven, study management deliverables related to clinical trials through excellent customer service, effective project management, strong working relationships across business lines, and the proper utilization of study management resources.
  • Shape effective, operational program strategies for Ophthalmology, AI/ID, and CVMED development plans, program feasibilities, and program level vendor and recruitment strategies Champion the implementation and use of harmonized, consistent processes and excellence in study management deliverables related to cost-effective, timely, and high-quality clinical trial data Effectively manage study management resources according to project needs and priorities through the utilization of resource forecasts and assignment tools for Oph.
Director
May 2011 to Current
Primrose School
Clinical Project Manager
February 2009 to June 2009
  • Role in addition to PSM responsibilities: Protocol team leader responsible for the successful execution of the clinical study, from protocol outline development through final study report.
  • Also responsible for and manage study deliverables through internal and external resources and act as the primary point of contact in managing the interfaces across the protocol team, vendors and service providers.
  • Assumed, at the request of upper management, the role of the Clinical Project Manager for the Ophthalmology Dry Eye program while continuing my Program Study Manager responsibilities.
ICT Program Manager
January 2008 to March 2008
  • Role in addition to PSM responsibilities: Hand-picked to manage the highest priority initiative within Development Operations.
  • Responsible for successfully implementing the timelines and metrics to evaluate effective process changes and progress toward reducing FAP to LSFV cycle time.
Associate Director
January 2007 to July 2007
  • Global Clinical Trial Management, Development Operations Manage and ensure high quality, timeline driven, study management deliverables related to clinical trials through excellent customer service, effective project management, strong working relationships across business lines, and the proper utilization of study management resources Shape effective, operational program strategies for Ophthalmology, AI/ID, and CVMED development plans, program feasibilities, and program level vendor and recruitment strategies Champion the implementation and use of harmonized, consistent processes and excellence in study management deliverables related to cost-effective, timely, and high-quality clinical trial data Effectively manage study management resources according to project needs and priorities through the utilization of resource forecasts and assignment tools for Ophthalmology and CVMED Study management experience in Phase I - III studies including study conduct from study start-up to study closeout including man.
Associate Director, Process Engineer
January 2006 to June 2006
Primrose School
  • SOPs, Training & Process (STP) Managed multiple projects and study-level zones focusing on the processes and metrics (cost, quality and speed) while setting standards in a global environment.
  • Utilize established and proven methods of Project Management to better serve Worldwide Development and Worldwide Pharmaceutical Sciences.
  • Global Implementation Lead for a number of Business Process Improvements, focused on maximizing WWD's partnership with WWPS.
  • Continuous Improvement "Yellow Belt" Trained (LEAN, SixSigma, and AIM principles) Global Implementation Lead for the WWD/WWPS Five Initiatives to Improve Clinical Drug Supply Delivery (Service Level Agreement, Clinical Drug Supply Forecasting, Clinical Drug Supply Overage Guidance, Clinical Supply Request Form, Clinical Drug Supply Label Design and Approval).
  • In-depth understanding of project management and implementation techniques.
  • Supported project management activities for development strategic projects; maintains project plans and other project docum.
IVRS Vendor Project Manager
January 2003 to March 2003
Parexel
  • Protocol Administration Group (PAG).
  • Successfully managed all operational aspects from Protocol Review, Request for Proposal, study start-up, maintenance and close-out for clinical teams related to Interactive Voice Response Systems.
  • Successfully reduced the overall budget for outsourced IVRS by 40% through the addition of multiple, competitive IVRS Vendors, establishing a fixed cost model, and standardization.
  • Established proven methods of Project Management to better serve the study teams and IVRS Vendors in order to create a win-win situation.
  • Provide comprehensive oversight and workload management for PAG-IVRS Vendor Services resources and IVRS Vendors.
  • Merck IVRS Coordinator 09-Sep-2002 - 25-Apr-2003.
  • Worked with Clinical, Drug Safety, Pharmacy and the IVRS Department to successfully manage multiple IVRS vendors, standardized system design and reporting, implementation and execution of live IVR systems, and project manage over 15 - 20 protocols (Phase II - IV).
Regional Clinical Research Associate
error: 2002 - 21 to August 2002
Council For A Strong America
  • Managed multiple clinical centers to establish best working practices, regulatory and data records keeping, and safe drug storage and distribution across therapeutic areas including Women's Health, Cardiovascular, Immunology, Anti-Invectives, and Central Nervous System.
  • Oversight and interaction with clinical research sites.
  • Maintain ongoing clinical research site correspondence and site files.
  • Review of patient charts and clinical research data.
  • Complete visit reports and maintaining study-related databases.
May 2001 to January 2001
  • Lead CRA for two Global Phase II & III Osteoporosis & Women's Health Trials.
  • Study management experience in Phase II - III studies including study conduct from study start-up to study closeout including management of CROs.
  • Assisted country teams and CROs in developing plans to promote consistency of monitoring and data management.
Lead Drug Metabolism Technician
May 1998 to January 1998
  • for novel drug candidate research that independently prepared study protocols and communicated results in writing and oral formats to supervisor and project team members.
  • Developed, validated and performed analytical techniques using LC/MS, GC/MS, and HPLC.
Education
Bachelor of Science : Chemistry Sociology/Criminology, May 1994West Virginia Wesleyan College - City, State
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Resume Overview

School Attended

  • West Virginia Wesleyan College

Job Titles Held:

  • Lead Clinical Research Associate
  • Assistant Scientist
  • The Director
  • Director
  • Clinical Project Manager
  • ICT Program Manager
  • Associate Director
  • Associate Director, Process Engineer
  • IVRS Vendor Project Manager
  • Regional Clinical Research Associate
  • Lead Drug Metabolism Technician

Degrees

  • Bachelor of Science : Chemistry Sociology/Criminology , May 1994

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