Clinical Study Manager

SmartRecruiters, Inc.; New York (NY); On-site; USD 80,000 - 113,000; Full time

Job summary

SmartRecruiters, Inc. is seeking an experienced Regulatory Submissions Manager to support US FDA submission activities for oncology programs. You will participate on cross-functional teams, coordinate with external partners, and help ensure compliant timely filings.

This contract role in New York offers $70/hr for six months, with a focus on regulatory strategy, oversight of budgets, and interaction with clinical operations and vendors as needed.

Qualifications

• 3-5 years of relevant regulatory and submissions experience.
• Experience with US FDA submission processes and oncology programs.
• Strong project management skills across cross-functional teams.

Responsibilities

• Participate on a cross functional team focused on US regulatory submissions (FDA).
• Provide regulatory submission oversight and budgeting input.
• Collaborate with AP/CRO and external partners for timely filings.
• Support Practical Clinical Trial Design and protocol feasibility discussions.

Skills

Regulatory submissions

Project management

Oncology experience

FDA submissions

Budget management

Cross-functional teamwork

Job description

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job.

Qualifications

• 3-5 years
• Strong Project Management
• Regulatory submission experience
• Oncology experience
• Participate on a cross functional team focused on US regulatory submissions (FDA).
• * Previous Pfizer experience is preferred; Pharmaceutical/biotech experience mandatory.
• Familiarity with U.S. NDA processes required
• Provides Financial Oversight
• Forecasts and manages high level clinical trial budget. Oversees the study risk planning process (e.g. IQMP)
• Works proactively with AP/CRO
• Supports Practical Clinical Trial Design
• o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design.
• o Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed.
• o Facilitates early engagement of Alliance Partners/Vendors when needed.

Additional Information

$70/hr

6 months