Overview
The Contract Manager is responsible for ensuring clinical trial agreements are negotiated in line with organizational standards and policies by managing site-level study budgeting and contracting.
Responsibilities
- Facilitate study contract and budget negotiation for research sites with sponsors, CROs, and vendors as needed.
- Work closely with internal and external stakeholders to manage or troubleshoot study start-up, legal, and budgetary challenges.
- Comply with current protocols, SOPs, GCPs, IRB, and FDA guidelines.
- Create, negotiate, submit, and modify study budgets based on organizational requirements and legal guidance.
- Coordinate budget details with other departments as appropriate and support execution of agreements with sponsors and CROs.
- 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 the financial viability of studies.
- Prepare cost estimates for Business Development for opportunities/RFPs.
- Review, negotiate, and finalize study amendments.
- Provide support and recommendations as needed for study feasibility and pre-study selection.
- Analyze data to identify trends and areas for improvement in contracting pricing and process (as needed).
- Provide information to management by assembling and summarizing data and preparing reports as requested.
- Hire, train, supervise, and evaluate personnel; enforce best practices and compliance with FDA Code of Federal Regulations, ICH, GCP, organizational SOPs, site working practices, protocols, and company guidelines and policies.
- Retrain and implement corrective and preventative actions as needed.
- Perform other duties and responsibilities as assigned.
Requirements
- Bachelor’s degree in finance, accounting, or related field.
- 5+ years minimum experience in contract management, financial analysis, forecasting, general accounting, or comparable experience.
- Experience drafting, reviewing, and negotiating business contracts.
- Strong analytical and negotiating skills.
- Excellent communication skills (written and verbal).
- Highly organized and efficient; ability to manage multiple competing tasks.
- Keen attention to detail.
Preferred Qualifications
- Prior experience working within the clinical research industry.
Compensation & Benefits
- Highly competitive compensation.
- Full-time benefits available after 30 days of employment, including:
- Health Insurance
- Dental
- Vision
- LTD
- STD
- Life Insurance
- 401k
Location & Working Conditions
- Remote work arrangement.
- Indoor, office environment.
- Essential physical requirements include sitting, typing, standing, and walking.
- Lightly active position; occasional lifting of up to 20 pounds.
- Reporting to work as scheduled is essential.
- Occasional/periodic travel to sites.