Clinical Trials Lead

Requirements:

• Bachelor’s degree required with an advanced degree preferred.
• Minimum of 8 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 1-2 years in a leadership position directing system, process, program or quality activities.
• Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills.
• Experience in clinical trial, data, or technology management
• Knowledge of GCP/ICH guidelines, regulations
• Experience with Investigator Sponsored Research (ISR), Expanded Access, Compassionate Use and Named Patient Program (NPP) practices and principles
• Experience with Regulatory requirements with regards to Investigator Sponsored Research and associated capabilities
• Understanding of ISR, Expanded Access, Compassionate Use and NPP needs, challenges and opportunities in clinical research
• Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
• Knowledge of Veeva Vault and Salesforce.com capabilities
• Ability to analyze and interpret complex issues and propose innovative solutions
• Experience with leading teams and driving innovation
• Strong project management and planning skills
• Effective oral and written communication skills to influence, inform, or guide others
• Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings.
• Experience working in a matrix environment.

Job Types: Full-time, Contract

Salary: $15.00 - $70.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Lawrence, NJ: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Bachelor's (Preferred)

Experience:

• leading and managing clinical trial: 8 years (Preferred)
• Investigator Sponsored Research (ISR): 5 years (Preferred)
• Veeva Vault: 4 years (Preferred)
• Pharma industry: 8 years (Preferred)

Work Location: One location