Executive Director, Global Clinical Trial Operations, Oncology
Location
New Jersey + 1 moreAll locations: New Jersey, Pennsylvania
Posted
9 days ago
Salary
$255.8K - $402.7K / year
Bachelor Degree10 yrs expEnglishGoogle Cloud Platform
Job Description
• The Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for Global Clinical Trial Operations (GCTO) country operations
• Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential
• The position is accountable for trial quality and audit responses and completion of CAPAs
• Ensures a single point of contact for managing clinical trial execution in all its aspects across phases in scope of GCTO within the country/cluster
• Supports the regional GCTO leadership team, leading strategic development of their country/ cluster to deliver clinical trials as per global clinical research pipeline requirement
• Strategic country/ cluster representative for initiatives at all levels of the organization.
• Build and lead the team to effectively manage resources ensuring appropriately skilled and high performing team to effectively deliver the portfolio across therapy areas and achieve on agreed GCTO, GCD, and Research and Development objectives
Job Requirements
- 10 years or more experience in Clinical Trials
- 5 years or more people management experience
- Experience in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and clinical trials from study initiation to completion and associated regulatory submission and inspection preparation
- Complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required
- Strong Communication skills requiring proficiency in written and spoken English and preferably local language
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days