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Research Development Consultant Resume Profile

Cincinnati, OH

PROFESSIONAL SUMMARY

Results-oriented and dedicated professional with 20 years of successful experience planning, managing and implementing clinical, decision support and scientific research projects. Experience leading complex projects from inception to completion with exceptional ability to analyze and solve problems by streamlining processes, improving productivity, while minimizing resource consumption

AREAS OF EXPERTISE:

  • Clinical Research
  • Strategic Planning and Execution
  • Operations Management
  • Analytical Skills
  • Contingency Planning
  • Organization Time Management
  • Project Management
  • Clinical Decision Support
  • Risk Identification Mitigation
  • Change Management
  • Process and Performance Improvement
  • Creative Resourceful Problem Solving

PROFESSIONAL EXPERIENCE

Confidential

Research Development Consultant

  • Led all pre-study qualification and study start-up activities
  • Collaborated with legal and regulatory experts
  • Prepared budgets, facilitated budget negotiations and finalized contracts
  • Primary point of contact for all industry sponsored research projects
  • Responsible for monitoring clinical trial finances and for ensuring proper payments
  • Drove a 200 increase of industry contracts

Clinical Research Manager

Confidential

  • Established best practices through market research, literature reviews and internal/external benchmarking
  • Streamlined processes, redesigned work flows, standardized procedures and redesigned job roles
  • Identified areas of risk and developed a risk mitigation plan
  • Collaborated to design, implement and monitor change management plans
  • Established and collected metrics for performance reporting
  • Accountable for the oversight of 70 clinical research projects and a staff of 40
  • Increased subject enrollment by 27 new clinical studies by 61 and total procedures by 114
  • Eliminated a 300K annual loss in 1 year by restructuring the Nutritional Research component of HIRC
  • Effectively used cross functional teams to manage clinical studies including Phase 1-4 Clinical Trials

Confidential

Project Manager

  • Led and managed an International Clinical Trial enrolling 4000 subjects from 19 sites in the US and UK
  • Improved overall productivity and efficiency by instituting project management methodologies, clear communication and accountability, clarification of roles and responsibilities, and the development of SOPs
  • o Administered a 800K annual operating budget
  • o Directed start up activities including pre-study qualification, initiation and training visits, budget negotiations and completion of the Clinical Trial Agreement, and product supply and shipping
  • o Established site monitoring plans, reviewed progress, managed risks and resolved problems
  • o Organized and made presentations at the annual Investigator Meetings
  • Led the development and implementation of a clinical outcomes research study. Assisted in protocol development, maintained regulatory and study records, and collaborated in database design
  • o Enrolled 160 patients in 106 days 93 of the eligible patient population

Confidential

Project Manager

  • Successfully managed a variety of projects including the construction and renovation of the Simulation Center
  • Functioned as the Client's Project Manager. Communicated with contractor regarding project status and to resolve issues related to site construction, procurement and engineering
  • Collaborated with contractor's project manager regarding adherence to project timeline and budget
  • Managed project scope, change management, scheduling and cost control
  • Formalized the Simulation Center's infrastructure including policy and procedure development, standardization of course development evaluation criteria, and automation of data collection
  • Collaborated with marketing experts to develop marketing and communication plans

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