General Information

Location: Cary, NC

Organization: Clintrax Global

Job Type: Full Time

Description and Requirements

The Contracts Manager, in our Cary, NC office location, leads the contract negotiation process with clinical trial sponsors and sites. The Contracts Manager drives the successful execution of site contract processes and performances across studies and works closely with the assigned Legal Counsels, Contracts Associates and Project Associates to provide leadership and support. The Contracts Manager is the point of escalation for site contract issues and works alongside the Site Contract Analyst to proactively identify, resolve/mitigate and escalate study risks or issues.

Education Requirements: 

  • Bachelor’s degree required

Qualifications/Experience Requirements:

  • Minimum of two years of experience in clinical trial setting and/or pharmaceutical industry required.  

  • Prior supervisory experience demonstrating leadership expertise. 

  • Must have two or more years of experience negotiating investigator contracts. 

  • Must have advanced knowledge of Microsoft Word, Excel, and Outlook. 

  • Ability to work independently, and be a pro-active team player is required. 

  • Must possess excellent verbal and written communication skills. 

  • Ability to proof-read and detect errors in typing, spelling, grammar, syntax and punctuation required. 

  • Medical terminology preferred.

Essential Duties/Responsibilities:

  • Oversee global contract negotiation and ensure contracts are executed on or ahead of schedule.

  • Work closely with CRO and Sponsor stakeholders to identify site, country and study-specific contracting intelligence and risks to clinical trial start-up, and developing risk mitigation strategies.

  • Conduct project review meetings to lead financial and contract success at the appropriate management level.

  • Negotiate contract terms, pricing and payment schedule, ensuring that the agreements with investigative sites are aligned with clients’ interests, as needed.

  • Work closely and communicate with clients, vendors and other internal stakeholders; provide timely updates on contract and site budget status’, identifying and escalating any potential critical path items as appropriate.

  • Work collaboratively with Legal Counsel and Contract Associates during the site contracting process. Serve as an internal escalation point during contract negotiations.

  • Serve as a point of contact for Site contract questions from within and outside the Company.

  • Work in collaboration with cross functional teams and external contract vendors to ensure timely contract execution.

  • Direct activities of Contracts Analysts and Project Associate Teams. This will include:

  • Ensure internal policies and procedures are followed by staff.
  • Coordinate and work with the Site Contracts team to ensure execution of site contracts on or ahead of the contracted schedule
  • Provide continuing support on executed agreements (e.g., drafting amendments, extensions and terminations, interpreting contractual language in response to issues or questions that arise).
  • Facilitate internal communications across departments
  • Draft Portfolio and Program Plans at the client level. Conduct Kick Off meetings with Clients and vendors.

  • Conduct risk review against Company milestones to identify and escalation risks to timelines posed by site contracts.

  • Provide department leadership and implement productivity improvements by performing metric collection and data analysis to support Clintrax’s continuous improvement in policies, procedures and business process

  • Maintain updated information of all study related information to use as reference in daily duties.

  • Stay abreast of changes in studies and/or updates to client preferences.

Supervisory Responsibilities:

  • Supervise the direct activities of Contracts Analysts and Project Associate Teams.

About Us:

Clintrax Global, Inc., a member of the WIRB-Copernicus Group family, specializes in the negotiation of clinical trial contracts and budgets between biopharmaceutical companies, contract research organizations (CROs), and investigator sites around the world. Clintrax Global has accelerated hundreds of clinical trials since its inception. Supported by technology-driven processes and a network of international attorneys, we have provided services across 65 countries.