Senior Scientific Manager, IRB Post-Approval Operations

NYU Grossman School of Medicine; New York (NY); On-site; USD 101,000 - 125,000; Full time

Job summary

NYU Grossman School of Medicine is seeking a Senior Scientific Manager to oversee post-approval IRB submissions and manage a dedicated team. Reporting to the Director of the IRB, the role ensures timely determination for post-approval activities, RNIs, and study closures, while maintaining compliance with federal, state, and NYU Langone Health policies.

The position requires strong leadership, advanced knowledge of human subject regulations, and superb organizational and writing skills.

Qualifications

• MA, MPH, MS or RN degree required.
• Strong knowledge of human subject regulations and policies.
• Excellent organizational, analytical, time management and interpersonal communication skills.
• Excellent verbal and technical writing skills; proficient with IRB software and MS Office.

Responsibilities

• Oversee day-to-day operations of post-approval team.
• Conduct quality assurance reviews using database reports to determine workload status.
• Ensure evaluations and deficiencies are communicated to the PI by pre-review staff.
• Work with pre-review staff to clarify deficiencies to the Investigator.
• Perform final review of continuations, amendments and study closures requiring expedited review.
• Verify completeness of applications and documentation using checklists.
• Analyze submission documents for compliance with NYULH policies and regulations.
• Follow up with PIs on outstanding issues from pre-review for RNIs and amendments.
• Relay all decisions to PIs via official IRB correspondence.
• Attend board meetings as a voting member when needed.

Skills

Verbal communication

Technical writing

MS Word

PowerPoint

IRB Software

Data analysis

Education

MA, MPH, MS, or RN

Job description

NYU Grossman School of Medicine is seeking a Senior Scientific Manager to oversee post-approval IRB submissions and manage a dedicated team. Reporting to the Director of the IRB, the role ensures timely determination for post-approval activities, RNIs, and study closures, while maintaining compliance with federal, state, and NYU Langone Health policies.

The position requires strong leadership, advanced knowledge of human subject regulations, and superb organizational and writing skills.