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CenExel is seeking a Clinical Contracts Manager to facilitate study contracts and budget negotiations with sponsors, CROs, and vendors. You will manage study start-up, legal and budget challenges, and coordinate with internal stakeholders to keep trials on track.
You will draft, review and negotiate budgets, analyze data to improve contracting processes, ensure compliance with FDA regulations, ICH, GCP and SOPs, and mentor staff as needed.
Facilitate study contract and budget negotiations for CenExel research sites with sponsors, CROs, and vendors
Manage and troubleshoot study start-up, legal, and budgetary challenges with internal and external stakeholders
Create, negotiate, submit, and modify study budgets based on company requirements and legal guidance
Communicate with sponsors and CROs through agreement execution
Coordinate budget details with other departments
Collaborate with Clinical Operations, Business Development, and Finance to support timely site start-up of new clinical trials, including periodic travel to sites
Prepare budgets for new studies and evaluate financial viability
Prepare cost estimates for Business Development opportunities and RFPs
Review, negotiate, and finalize study amendments
Support study feasibility and pre-study selection processes with recommendations
Analyze data to identify trends and areas for improvement in contracting pricing and processes
Assemble and summarize data and prepare reports for management
Hire, train, supervise, and evaluate personnel
Champion and enforce adherence to FDA regulations, ICH, GCP, SOPs, site working practices, protocols, and company policies
Retrain staff and implement corrective and preventive actions as needed
Assume other assigned duties and responsibilities
Demonstrates expertise in contract management, financial analysis, and budget negotiation within the clinical research industry, ensuring compliance with FDA regulations and GCP standards. Strong analytical skills and attention to detail support effective communication and collaboration across departments.