Randstad Clinical Operations in Madison, New Jersey

Clinical Operations

job details:

  • location:Madison, NJ

  • salary:$66.66 - $78.43 per hour

  • date posted:Wednesday, July 18, 2018

  • job type:Contract

  • reference:25856

job description

Clinical Operations

Senior Contracts Manager

Job Summary

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

Job Responsibilities

  • Clinical Trial Agreement (CTA) Management.

  • Develop CTA per patient budgets using GrantsManager

  • 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.

  • 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.

Education & Qualifications

  • 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 preapproval 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/GrantsManager a plus.

  • Project Management

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.