Site Contract Specialist

About the role

The Site Contract Specialist manages the preparation, negotiation and finalization of contracts with study sites, ensuring quality, objectivity and risk analysis in the delivery of Investigator Contracts. The role liaises with sites and internal teams, may involve mentoring junior staff, and works within the PPD clinical research services, which support clinical trials from start-up to close-out.

Key responsibilities

• Draft, review, negotiate and finalize agreements with study sites according to local and accepted processes.
• Negotiate investigator grant budgets, contractual terms and conditions within approved parameters, following escalation routes and client expectations.
• Ensure compliance with budgetary guidance, templates and processes, and identify and escalate legal, financial and operational risks.
• Provide recommendations and alternative resolutions to contract negotiations through established channels.
• Coordinate with internal departments so site startup activities align with contractual activities and timelines, and meet target cycle times for site activations.
• Escalate out-of-parameter issues, complete tracking and reporting, and take part in country process improvement initiatives.
• Liaise with Global Site Contracts, complete quality reviews and peer feedback reports, and act as country subject matter expert on Investigator Contracts training materials.
• May act as lead on amendment and novation client projects and oversee confidentiality agreement negotiations.

Required profile

• Bachelor's degree or equivalent, and relevant formal academic or vocational qualification.
• Previous experience comparable to 5+ years; equivalency through education, training and related experience may be considered.
• Knowledge of contract law, including business, intellectual property, local tax and stamp laws.
• Effective verbal and written communication in English and the local language.
• Ability to negotiate investigator grant budgets and Investigator Contracts within parameters, and to analyze and resolve contractual risks.
• Ability to work independently or in a team, with good organization and time management.
• Ability to train and mentor staff and give constructive feedback to Investigator Analysts.

Required skills

• Working knowledge of PPD SOPs and WPDs.
• Use of automated systems and computerized applications.
• Attention to detail and analytical, decision-based thinking.