Jazz Pharmaceuticals seeks a Senior Study Start-Up Specialist to produce high-quality deliverables for clinical trial site activation. This role involves collaborating with cross-functional teams to ensure compliance, track progress, and analyze data to enhance site activation timelines while maintaining a focus on continuous improvement.
Key Responsibilities
Identify and resolve site-related issues during the start-up process
Manage preparation and submission of regulatory documentation
Collect and maintain regulatory submission information
Ensure clinical trial insurance and agreements are in place
Manage SSU data tracking entries
Participate in project meetings and provide updates on site activation activities
Required Qualifications
Pharmaceutical or related industry experience
Regulatory and study start-up experience
Excellent knowledge of GCP and regulations
Ability to mentor, motivate, and lead junior staff
Excellent attention to detail and problem-solving skills
Advanced knowledge of Word, Excel, and PowerPoint
Preferred Qualifications
Experience with in-house trials/process design
Previous mentoring or people management experience
Benefits & Perks
Medical, dental and vision insurance401k retirement savings planFlexible paid vacationDiscretionary annual cash bonus or incentive compensationDiscretionary equity grants