Site Contract Specialist

Overview:

Our client is a leading full-service Contract Research Organisation with offices across the globe, our client has been providing its clients with dynamic and high-quality clinical services. Providing their clients with services including but not limited to data management, regulatory affairs, bio statistics, and clinical trials they have built a solid reputation on their breadth of knowledge and service level. The Site Contract Specialist role is to work for just one sponsor within an FSP model.

Responsibilities:

• Lead multi-country projects including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Generates site-specific contracts from country clinical trial agreement (CTA) template. Evaluates and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review.
• Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata. Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Generates amended contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Provides support to business development and represents site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Maintains and actively supports review and development of contract templates, budget templates and site-specific files and databases.
• Serves as key communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence, as necessary.
• Trains and mentors less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensures quality of teamwork products. Maintains and updates training material for site contract team.

Qualifications:

• BA/BS degree in Business Administration, Public Administration, Public Health, related field, or equivalent combination of education and experience.
  * Moderate contracts management experience that includes experience in a contract research organisation or pharmaceutical industry
  * Management experience preferred
  * Robust knowledge of the clinical development process and legal and contracting parameters
  * Outstanding understanding of clinical trial start-up processes
  * Quality-driven in all managed activities
  * Solid negotiating skills
  * Strong problem-solving skills
  * Capability to mentor and motivate more junior staff

Why this opportunity is right for you

• Fantastic opportunity to work with a fast-growing CRO
• Work for just one sponsor within an FSP model
• Supportive line managers
• Excellent career progression paths