VP, Compliance – Regulatory Initiatives – Policies and Procedures
TD
Job Level
Senior
About the role
- Review, negotiate and manage clinical trial site contracts and clinical budgets
- Conduct Fair Market Value (FMV) assessments and contract/budget reviews
- Perform independent contract review and site engagement
- Manage 45+ agreements and maintain oversight for assigned sites
- Track and maintain compliance of contract statuses in the reporting system
- Collaborate with internal and external partners and stakeholders
- Identify, manage risks and resolve conflicts related to contracting
- Support project management and service delivery for clinical studies
- Apply legal analysis and knowledge of local contracting procedures
- Work across early Phase study requirements and related risk factors
Requirements
- Bachelor’s Degree or international equivalent
- 3+ years’ experience with contracts
- Two or more years industry experience required
- Read, write and speak fluent English; fluent in host country language required
- Prefer JD or advanced degree
- Clinical trial contracts and clinical budgets negotiations experience with clinical sites (Required)
- In depth knowledge of Fair Market Value (FMV)
- In depth knowledge of contract and budget review process
- Strong foundation in analytical thinking and legal analysis
- Familiar with legal language
- Proficient at independent review and site engagement
- Firm understanding of early Phase studies and their related risks/requirements
- Knowledge of local contracting procedures
- Ability to manage 45+ agreements and maintain a pulse on each assigned site
- Ability to track and maintain compliance of contract status’ in the reporting system
- Excellent written and verbal communication
- Thorough attention to detail
- Time management skills
- Self-starter with collaborative mindset & ability to work independently
- Ability to effectively manage risks and resolve conflicts
- Ability to be highly collaborative with internal and external partners
- Capable of succeeding in fast paced environments
