Clinical Trial Associate

  • location: Madison, NJ
  • type: Contract
  • salary: $63.33 - $74.51 per hour
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job description

Clinical Trial Associate

Job Title: Senior Contracts Manager

Job Summary

The role of the Contract Manager is to create, negotiate and execute all study contracts, contract amendments, and budgets required for Clinical Trials (Phases II-IV)

Job Responsibilities

1. Clinical Trial Agreement (CTA) Management.

  • Develop CTA per patient budgets using Grants 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.
2. Ensure contracts are executed within fair market standards as appropriate.

3. Answer questions and resolve problems concerning all assigned studies and individual contracts.

4. Track workflow and contract cost for all assigned studies and individual contracts.

Education & Qualifications

  • Education: BA/BS Degree
  • Experience: 3-5 years of experience creating, negotiating and executing Clinical Trial Agreements in a pharmaceutical or biotech company or Contract Research Organization (CRO).
  • Licensure/Credentials: None
  • Knowledge, Skills, and Abilities: Knowledge of the pre-clinical, clinical, and pre-approval 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 GrantPlan 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, Judgement
Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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