Remote Clinical Trial Manager

37827986 Remote Clinical Trial Manager, Ridgefield, CT 12 Months Contract

Sigma Systems is seeking a Remote Clinical Trial Manager

Responsibilities:

• The Clinical Trial Contract Manager is responsible for assurance that clinical trial /site budget is of high quality and allocations are within fair market values.
• This role is responsible for the development and maintenance of Sites Fee Framework as well as timely and accurate coordination, processing, monitoring, and administration of payments to sites according to budget and terms.
• The incumbent will be responsible for the support of management goals and objectives of the department.
• 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).
• Ability to build clinical trial site budget and ensures it is of high quality and allocations are within fair market values (FMV); analyze protocol flowcharts to create costing, payment strategies, and budget estimates and negotiation prameters within FMV.
• Drives development and maintenance of Site Fee Framework
• Sets up, closes, re-opens, and submits payments within all grants.
• Effectively uses budget-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables.
• Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable the Budget group to deliver value and enhance overall operational effectiveness.
• Actively remains current with industry standards, trends, and competitive intelligence on budget best practices.
• Interfaces across Medical, all TAs, Finance, Legal, and external parties e.g., investigators, site personnel, third party vendors.
• Liaises within Clinical Trial Manager and TA Lead for review and approval of budget
• Liaises with Clinical Finance/Accounting Department, Legal Department (if needed) and the local Head of Clin Ops and/or Clinical Operations Management for approval of payment related decisions (e.g., standard payment frequency) and maintain proper documentation.
• Represents Contract/Budget group processes on local/global working groups.
• Ensures commitment to customer-centric behaviors.
• Maintains high degree of responsiveness to both internal and external requests

Requirements:

• Bachelor's degree with minimum of five (5) years of relevant business experience in regulated pharmaceuticals or healthcare industry.
• Strong clinical background and budgeting understanding of cost drivers and benchmarks for clinical site budget.
• Ability to think strategically and initiate strong and persuasive contractual arguments to support business policies and objectives.
• Track record in setting priorities, organization and problem-solving skills which support and enable sound decision making.
• Excellent customer service skills and high attention to detail.
• Demonstrated analytical skills and critical thinking to resolve issues in a variety of complex situations requiring new solutions.
• Excellent written and verbal communication skills and the ability to be clear and concise in a variety of communication settings.
• Experience in working with systems, applications related to clinical and/or project management planning and reporting systems.
• Excellent knowledge of computer applications (Excel, Word, Access) is essential. Knowledge of Veeva is a plus.