FSP Contract Negotiator

Overview

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

Responsibilities

• Develop and coordinate investigator grant development and estimates, contracting strategies, and proposal text to support proposal development.
• Draft contract language, payment language, and budget templates as applicable to the position.
• Use and maintain contracting systems, tools, processes, and training materials for assigned sponsors, studies, or multi-protocol programs in accordance with the Scope of Work and Project Plan and the agreed project strategy.
• Coordinate cross-functional collaboration, including communication with sponsors, stakeholders, and RSU regions and countries as applicable, to deliver 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 as applicable to site agreements, facilitating clinical trial business development, initiation, and ongoing maintenance while supporting regulatory compliance.
• Create and/or review core scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance.
• Collect, interpret, analyze, and disseminate accurate contracting intelligence to support assigned studies and broader organizational needs.
• Ensure contracting efficiency and adherence to project timelines and financial goals as applicable to site agreements.
• Report contracting performance metrics and out-of-scope contracting activities as required.
• Partner with Quality Management to support appropriate contract management and quality standards; mentor and coach colleagues and deliver training materials as needed.
• Deliver client presentations as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines, and project plans.
• May help develop and sustain 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 serving as a contract negotiator. Equivalent combination of education, training, and experience will be considered.
• Strong negotiating and communication skills, with the ability to challenge when appropriate.
• Good interpersonal skills and demonstrated ability to work as 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.
• Strong organizational and planning skills.
• Strong 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.
• Strong understanding of specific sponsor or stakeholder needs and ability to share that knowledge effectively.
• Ability to use metrics and communicate them to the study team to establish timelines for deliverables.

Compensation & Benefits

• The potential base pay range for this role, when annualized, is $49,200.00 - $157,100.00.
• Actual base pay offered may vary based on job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time).
• 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, depending on the position.