Parexel FSP are recruiting for an experienced Clinical/Site Contract Specialist to join a key sponsor in the UK.  

As Contract Manager you will be responsible for direct site facing contract and budget negotiations through contract execution with assigned clinical sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies.

Some specifics about this advertised role

• Review and negotiate Confidential Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs), and Informed Consent Forms (ICFs), either directly or as escalated by Contract Research Organizations (CROs)
• As required, oversee CRO or Functional Service Provider in the development of clinical site budgets and partner with clinical operations to ensure budgets are in line with study protocols.
• Serve as an expert in client Contract Management System (CMS) and processes
• Work closely with Legal Operations and the CMS teams to ensure contracts are properly managed in the system and develop enhancements, improvements and updates
• Develop, maintain, and analyze tools and systems (spreadsheets, Smartsheet, databases, etc.) to manage contract lifecycle from initiation through contract execution, and build internal metadata to support accurate reporting.
• Provide guidance and direction to new clinical operations and/or outsourcing team members and R&D teams on site contracts & budgets processes

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

What we are looking for in this role

For every role, we look for professionals who have the determination and courage always to put patient well-being first.

That to us is working with heart.

Here are a few requirements specific to this advertised role.

• Minimum 5 years of contracting experience
• Experience negotiating CDAs, CTAs, and ICFs, either in a pharmaceutical/biotech company or CRO
• Experience negotiating with a Contract Management System (CMS) required
• Excellent verbal, written and interpersonal communication skills in a dynamic and growing organization.
• Working knowledge of clinical trial functions, including clinical operations, regulatory and drug safety.
• Ability to prioritize and manage multiple tasks simultaneously.