Overview
This role supports selected sponsors, studies, or multi-protocol programs by developing global contracting strategy and delivering required start-up contracting activities. Responsibilities include creation and review of investigator grants, contracting and budget templates, negotiation-ready contract/payment language, and contracting performance reporting.
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.
- Utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies, or multi-protocol programs in line with the Scope of Work and Project Plan and the agreed project strategy.
- Collaborate with sponsors, stakeholders, and RSU regions and countries as applicable to ensure delivery of 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, to facilitate efficient business development, trial initiation, and trial maintenance while supporting compliance with regulatory requirements.
- Assist with creation and/or review of core scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance as required.
- Collect, interpret, analyze, and disseminate accurate contracting intelligence to support assigned studies and broader internal needs as required.
- Ensure contracting efficiency, adherence to project timelines, and alignment with financial goals as applicable to site agreements.
- Report contracting performance metrics and out-of-scope contracting activities as required.
- Partner with Quality Management to ensure contract management and quality standards are met; mentor and coach colleagues as required and deliver training materials as needed.
Qualifications
- Bachelor’s degree in a related field.
- 3–5 years of relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/or regional experience acting as a contract negotiator. Equivalent combination of education, training, and experience may be considered.
- Good negotiating and communication skills, with the ability to challenge.
- Strong legal, financial, and/or technical writing skills.
- Strong understanding of the regulated clinical trial environment and knowledge of the drug development process.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Knowledge of applicable regulatory requirements, SOPs, and corporate standards.
- Good understanding of clinical trial contract management.
- Ability to develop and suggest alternate contracting language, terms, and financial options.
Preferred Qualifications
- Sponsor-facing experience.
Compensation & Benefits
- The potential base pay range for this role, when annualized, is $49,200.00 - $157,100.00.
- 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 offered, 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.
Equal Opportunity
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
Integrity in Hiring
A zero-tolerance policy for candidate fraud is maintained. All information and credentials submitted must be truthful and complete; false statements, misrepresentations, or material omissions may result in disqualification of an application or termination of employment if discovered later, in accordance with applicable law.