Contracts Administrator Resume Example

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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • Home: (555) 432-1000
  • Cell:
An established professional with a Bachelor of Science in Chemical Engineering and a Masters in Business Administration with a strong compliance foundation and experienced in project management, proposal and budget development in research, post award contract negotiations, budget development and negotiation, proposal development, and new product development activities; detailed knowledge of quality assurance, analysis of complaints, process refinement, and process improvement techniques.
  • Policy and Procedure development
  • Statistical analysis
  • Project management
  • Analytical problem solving
  • Microsoft Excel
  • Microsoft PowerPoint
  • Quality Management
  • Process improvement strategies
  • Analytical
  • Personable
  • Process improvement strategies
  • Contract management in a Research environment
  • Relationship building
  • Microsoft Office Suite expert
  • Flexible
  • Dedicated
Contracts Administrator, 11/2015 to 2017
The Kemtah GroupWayne, NJ,
  • Liaise with HHRI and HonorHealth Corporate Legal to manage, communicate and prioritize Clinical Trial/Research related contracts.  
  • Clearly and concisely communicate HHRI contractual obligations for Clinical Trials, Collaborations, HHRI PI initiated studies, Grants, and/or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed HHRI Business priorities and strategy.
  • Develop contracting strategies and provide approved proposal text to support the contracting process.
  • Develop and maintain the contract templates for Clinical Trial Agreements, Subcontractor, Non-Disclosure/Confidentiality Agreements, Master Agreements that pertain to Research or Clinical Trial Arrangements
  • Utilize and maintain a complete, concise and compliant contract database, Local Drives and Standard Work Processes for HHRI.
  • Collect, Interpret, analyze and disseminate accurate metrics and contracting intelligence to support HHRI studies
  • Perform final quality review of the negotiated contract to ensure all changes are captured for final execution
  • Collaborate with Project Management and Business Operations to ensure Regulatory and Compliance are fully informed to make strategic decisions 
  • Provide legal, operational and financial contracting support to facilitate efficient business development, initiation and maintenance of clinical trials, while enabling adherence to regulatory and compliance requirements.
  • Ensure overall contracting efficiency and adherence to project timelines and financial goals;
  • Report contracting performance metrics and out of scope contracting activities as required.
  • Mentor and provide legal guidance to colleagues as required

Project Manager, 01/2009 to 09/2015
Skanska Usa Building IncFort Lauderdale, FL,
  • Prepared budgets, scientific proposals, and negotiate contracts in support of Principle Investigators, Clinical Trials, Information Technology and Purchasing departments as well as for several institutional projects
  • Managed high priority institutional projects such as implementation of HIPAA and attainment of CLIA certification 
  • Utilized Sharepoint, as well as Microsoft office tools, to established efficient workflow for Policies and Procedures, editing, review and approvals by management and staff
  • Established nonprofit pricing module for CLIA tests for contracts and proposals    
  • Management of operational initiatives such as CLIA and HIPAA implementation        
  • Planned, coordinated international meetings and collaborations, Implemented Process Efficiencies and workflows ·       
  • Coordinated Xenografts models, contracts and compliance documentation for multi-institution research projects and preclinical trials
Regulatory Specialist/Quality Engineer, 01/2006 to 01/2009
Covance, ,
  • Collaborated with several new product development teams, in the Medical Device Industry to submit required regulatory documentation for 510k submissions, Research And Development documentation for regulatory submissions
  • Management of 510K device regulatory design files
  • Investigated International product complaint, adverse events for several devices
  • Implemented standardized Complaint Investigation processes for Off Shore manufacturing site
  • Report complaint metrics, compile reports from Post Marketing Surveillance reporting
  • Conducted engineering review/analysis of nonconformance disposition with root cause evaluation and elimination (Material Review Board)      

Quality Manager, 01/2004 to 01/2006
LeMaitre Vascular, ,
  • Successful Management of ISO 9001:2000, ISO 13485:1996, CMDCAS, MDD 93/43/EEC audit compliance for start-up medical device manufacturing company going through acquisition
  • Managed ISO 13485:2003 transition activities for maintenance of CE mark and interfaced with international regulatory representatives Responsible for vigilance and surveillance reporting for a startup medical device manufacturing company going through acquisition
  • Experienced with equipment validations, developing the Design of Experiments (DOE), Statistical Process Control and characterizations  Worked with a team to transfer processes for semiconductor manufacturing line from Toulouse, France to Tempe, Arizona
BS: Chemical Engineering, Expected in 1999
Arizona State University - ,
Chemical Engineering
MBA: , Expected in 2005
TM - University of Phoenix - ,
Microsoft Office Suite, Word, Excel, Powepoint Access,
Contract Management Data Base Management
Clinical Trials, Contract Management, Design of Experiments (DOE), documentation, editing, Information Technology, Insurance, ISO, ISO 9001, laboratory tests, mark, meetings, Excel, Microsoft Office, PowerPoint, MS Project, Sharepoint, 2000, Word, new product development, Policies, pricing, processes, proposals, Purchasing, reporting, research, scientific, Statistical Process Control, workflow, Adobe Acrobat,

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Resume Strength

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Resume Overview

School Attended
  • Arizona State University
  • TM - University of Phoenix
Job Titles Held:
  • Contracts Administrator
  • Project Manager
  • Regulatory Specialist/Quality Engineer
  • Quality Manager
  • BS
  • MBA