Site Contract Specialist

Position Overview

• Location Type: Onsite
• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Salary: Not provided

The Site Contract Specialist prepares and negotiates contracts with study sites, establishes relationships with internal and external teams, and ensures quality and risk analysis in the efficient delivery of contracts. This role is focused on streamlining site startup activities and improving timelines.

Requirements

• Education: Bachelor’s degree
• Experience: Previous experience (comparable to 2-5 years’) that provides the knowledge, skills, and abilities to perform the job.
• Knowledge, Skills, and Abilities:
  • Understanding of contract law principles.
  • General understanding of laws influencing contract language (business, intellectual property, local tax, and stamp laws).
  • Demonstrated ability to apply basic principles of investigator grant negotiation.
  • Previous experience in CRO is an advantage.
  • General understanding of business and financial principles.
  • Effective communication skills (verbal and written) in English and the local language.
  • Attention to detail.
  • Analytical and decision-based thinking.
  • Understanding of the pharmaceutical product development process and involvement of CROs.
  • Ability to work with appropriate oversight, drafting and negotiating contract provisions and budgetary issues within parameters.

Responsibilities

• Drafts, reviews, negotiates, and finalizes agreements with study sites in accordance with local/accepted processes.
• Negotiates within approved parameters, including investigator grant budget negotiation parameters, contractual terms and conditions, and client contractual considerations, following established process with sites and escalation routes.
• Ensures compliance to established negotiation parameters, authority approval, contractual process, and client expectations.
• Ensures compliance of budgetary guidance, templates, and process.
• Identifies and assesses legal, financial, and operational risks and brings up to the appropriate level of the organization per established processes.
• Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels.
• Coordinates with internal functional departments to ensure site startup activities are aligned with contractual activities and mutually agreed-upon timelines.
• Ensures alignment of contract negotiation process for sites and studies to the critical path for site activation.
• Achieves target cycle times for site activations.
• Ensures guidelines and processes are followed for efficient escalation of out-of-parameter issues as appropriate.

Application Instructions

• Not provided

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner, and safer.
• Activities: Goal-driven teams combine and deliver startup activities for clinical trials, collaborating to improve processes, cycle, and flexibility.
• Services: Partnering with sites, businesses, and colleagues around the world to decrease startup timelines and exceed expectations.
• Clinical Trials: Conducted in 100+ countries with ongoing development of novel frameworks for clinical research through its PPD clinical research portfolio.