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Contracts Manager for Clinical Trial Agreements

Alpha Consulting Madison Contractor
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Project Description: 
The role of the Contracts Manager is to create, negotiate and execute all study contracts, contract amendments, and budgets required for Client's Clinical Trials (Phases I-IV; this role has a Phase I concentration), Investigator Initiated Trials (IIT), and Pharmacology studies. 
  • Clinical Trial Agreement (CTA) Management. 
    • Develop CTA per patient budgets using Grant Manager. 
    • Draft study specific CTA templates. 
    • Finalize CTA templates and per patient budgets with study teams. 
    • Negotiate and establish pre-approval and approval workflows; review roles, task timelines and responsibilities; and negotiation parameters with study teams. 
    • Draft, negotiate, and execute site specific CTAs within established study timelines and study budgets. 
    • Develop, draft, and negotiate CTA amendments within established study budgets. 
    • Assist with managing the Data Driven Payment process for assigned studies. 
    • Lead and coordinate CTA management for large studies. 
    • Lead and coordinate CTA management for all studies within a project. 
  • Draft, negotiate, and execute contracts and contract amendments for Client and Pharmacology studies. 
  • Ensure contracts are executed within fair market standards as appropriate. 
  • Answer questions and resolve problems concerning all assigned studies and individual contracts. 
  • Track workflow and contract cost for all assigned studies and individual contracts. 
  • Engage in process improvement initiatives both inside and outside the Contracts Management Group (CMG). 
  • Provide some mentoring to junior associates within the CMG. 
  • Assist with developing and maintaining CMG procedures for contract management as needed. 
  • Support developing processes, standard templates, and quality definitions and metrics as appropriate. 
Required Skills:
  • BA/BS Degree.
  • 3-5 years of experience creating, negotiating and executing contracts in a pharmaceutical or biotech company or Contract Research Organization (CRO). 
  • Knowledge of the pre-clinical, clinical, and periapproval drug development process required. 
  • Advanced skills in Microsoft Outlook, Microsoft Word, Microsoft Excel, Microsoft Access.
  • Experience using Adobe Acrobat Professional and Microsoft Office SharePoint. 
  • Proficiency with specialized industry databases such as Grant Plan/Grants Manager a plus. 
  • Must possess excellent skill/ability in the following: 
    • Project Management 
    • Time Management 
    • Conflict Resolution 
    • Dealing with Difficult People 
    • Written Communication 
    • Organizing 
    • Initiative 
    • Decision Making 
    • Problem Solving 
    • Oral Communication 
    • Team Building 
    • Influencing Others 
    • People Relationships 
    • Accountability 
    • Judgment
This 9+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: URL blocked - click to apply


Recommended skills

Team Building
Time Management
Complex Problem Solving
Decision Making
Coaching And Mentoring
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Alpha Consulting
Corporation is a privately owned staffing firm operating from a single location
in East Brunswick, NJ. Alpha has staffed IT positions for major companies in
the pharmaceutical industry since 1994, with a special focus on project
management, product management, and program management.

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