Senior Clinical Research Counsel

Responsibilities

• Negotiate clinical trial agreements for multi-site, multi-country trials
• Advises on contracting risks and offers mitigation strategies
• Ensures compliance with federal, state, and international laws
• Affixes legal aspects of patient informed consent forms
• Develops and negotiates data protection and privacy agreements
• Create policies related to anti-kickback considerations
• Identifies process improvements for contract lifecycle management

Qualifications

• Juris Doctor degree
• Member of a State Bar Association (preferably California)
• 10+ years of experience at a large law firm or legal department in Life Sciences or Pharmaceutical sector
• Expertise in drafting and negotiating clinical trial agreements
• In-depth knowledge of laws and regulations governing clinical research (FDA, GCP, ICH)
• Excellent organizational and communication skills
• Strong analytical thinking and decision-making abilities