Contract Negotiator

Overview

This role develops the global contracting strategy and supports delivery of required start-up contracting activities for selected sponsors, studies, or multi-protocol programs, as defined by sponsor requirements.

Responsibilities

• Develop and coordinate the development of investigator grants and estimates, contracting strategies, and proposal text to support proposal development.
• Develop contract language, payment language, and budget templates as required for the position.
• Use and maintain contracting systems, tools, processes, and training materials for assigned sponsors, studies, or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
• Collaborate with sponsors, stakeholders, and relevant regions and countries to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
• Provide specialist legal, operational, and financial contracting support to study teams, including site agreements, to facilitate efficient business development and clinical trial initiation and maintenance while enabling compliance with regulatory requirements.
• Assist with the creation and/or review of core scientific, technical, and administrative documentation to support business development and study initiation/maintenance, as required.
• Collect, interpret, analyze, and disseminate accurate contracting intelligence to support assigned studies and broader organizational needs, as required.
• Ensure overall contracting efficiency, adherence to project timelines, and alignment with financial goals for site agreements, as applicable.
• Report contracting performance metrics and any out-of-scope contracting activities as required.
• Partner with Quality Management to ensure appropriate contract management and quality standards; mentor and coach colleagues as needed, including delivering training materials.
• Deliver client presentations as required.
• Ensure accurate completion and ongoing maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans.
• May help build and maintain long-standing relationships with preferred clients/customers.

Qualifications

• Bachelor’s Degree in a related field.
• 5 years of relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience acting as a contract negotiator.
• Strong negotiating and communication skills, including the ability to challenge.
• Strong interpersonal skills and ability to be a team player.
• Strong legal, financial, and/or technical writing skills.
• Strong understanding of the regulated clinical trial environment and knowledge of the drug development process.
• Knowledge of and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, SOPs, and corporate standards.
• Ability to exercise independent judgment and take calculated risks.
• Ability to lead, motivate, coach, and mentor.
• Good organizational and planning skills.
• Good presentation skills.
• Strong knowledge of Microsoft Office and email applications.
• Good understanding of clinical trial contract management.
• Ability to work effectively in a matrix team environment.
• Ability to establish and maintain effective working relationships with coworkers, managers, and sponsors.
• Ability to develop and suggest alternate contracting language, terms, and financial options.
• Ability to understand specific sponsor or stakeholder needs and communicate that knowledge effectively.
• Ability to use metrics and communicate them to study teams to establish timelines for deliverables.

Compensation & Benefits

• Potential base pay range (annualized): $62,800.00 - $157,100.00
• The actual base pay offered may vary based on job-related qualifications, including knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
• Depending on the position, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.