Clinical Trial Contract Manager

Job Title: Clinical Trial Contract Manager

Location: REMOTE

Type: Contract

Compensation: $60 an hour W2

Work Model: Remote – offsite

Hours: Monday - Friday; 1st Shift

Responsibilities

• Prepares, negotiates, and executes a variety of agreements

• Reviews contract language and prepares responses to negotiate contract modifications

• Maintains contract files and systems

• Maintains close working relationship with all Clinical Operations as well as Legal, Ethics & Compliance, and Clinical Development & Medical Affairs (CDMA)

• Builds clinical trial site budgets, ensuring high quality and allocations within fair market values (FMV); analyzes protocol flowcharts to create costing, payment strategies, and budget estimates and negotiation parameters within FMV

• Drives development and maintenance of Site Fee Framework

• Sets up, closes, re-opens, and submits payments within all grants

• Uses budget-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables

• Maintains a continuous improvement culture by identifying and executing strategies to enhance operational effectiveness

• Keeps current with industry standards, trends, and best practices in budgeting

• Interfaces with Medical, all TAs, Finance, Legal, investigators, site personnel, third-party vendors

• Liaises with Clinical Trial Manager and TA Lead for budget review and approval

• Coordinates with Clinical Finance/Accounting Department, Legal Department, and Clinical Operations Management for payment decisions and documentation

• Represents Contract/Budget group processes on local/global working groups

• Ensures responsiveness to internal and external requests

Requirements

• Bachelor's degree with minimum of five (5) years of relevant experience in regulated pharmaceuticals or healthcare industry

• Strong clinical background with budgeting knowledge of cost drivers and benchmarks for clinical site budgets

• Strategic thinking and ability to initiate strong contractual arguments aligned with business policies and objectives

• Proven ability to set priorities, organize, and solve problems supporting sound decision-making

• Excellent customer service skills with high attention to detail

• Demonstrated analytical and critical thinking skills for resolving complex issues with innovative solutions

• Excellent written and verbal communication skills, clear and concise in various settings

• Experience with clinical and project management reporting systems

• Proficiency in computer applications (Excel, Word, Access); Veeva knowledge a plus

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.