Clinical Research Sr. Project Manager

Jefferson Health Plans • Philadelphia, PA

2d • Onsite

About The Position

The Clinical Research Sr. Project Manager trains research staff, supervises staff and oversees clinical trials from start-up to close-out. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, and oversees research operation in department, and provides expert consulting at an institutional level.

Requirements

• Bachelors Degree and 5 years of clinical research experience or Master’s Degree and 3 year clinical research experience.
• 2+ years of lead/Project Management experience.

Responsibilities

• Manages all Investigator-lead multi-site trials by developing and implementing processes for document management and IRB submission tracking (i.e. continuing reviews and amendments) for multi-center trials as well as have protocol status knowledge.
• Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc.
• Provides direct supervision of the research staff which includes conducting on-going training, reviewing workloads, completing annual evaluations, etc.
• Oversees documentation efforts to ensure compliance with domestic and international regulations and standards.
• Identifies issues, recommends changes, writes new standard operating procedures (SOPs) or update existing SOPs with the goal of enhancing regulatory compliance.

Benefits

• medical (including prescription)
• supplemental insurance
• dental
• vision
• life and AD&D insurance
• short- and long-term disability
• flexible spending accounts
• retirement plans
• tuition assistance
• voluntary benefits
• tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior