Research Program Manager

Medasource; New York (NY); On-site; USD 60,000 - 100,000; Part time

Job summary

An innovative firm is seeking a dedicated Program Manager to lead fast-track cancer trials. This role involves managing clinical trial start-ups, maintaining sponsor relationships, and ensuring compliance with regulatory guidelines. You'll oversee protocol development, train research staff, and facilitate high-quality deliverables across multiple sites. Join a dynamic team in a mid-senior level position that offers the opportunity to make a significant impact in the healthcare and biotechnology sectors. If you are passionate about advancing cancer research and thrive in a collaborative environment, this role is perfect for you.

Benefits

Medical insurance

Vision insurance

Qualifications

• Experience in managing clinical trials and regulatory submissions.
• Strong knowledge of Good Clinical Practice and ICH Guidelines.

Responsibilities

• Oversee the Management Plan ensuring high-quality execution of work.
• Collaborate with PIs to complete study submissions to IRB and regulatory bodies.

Skills

Project Management

Regulatory Compliance

Clinical Research

Budget Management

Staff Training

Education

Bachelor's Degree

Master's Degree

Job description

The Program Manager will lead the implementation of a newly funded fast track cancer trials. The Research Program Manager is responsible for managing regulatory start-up of clinical trials, assisting development of investigator-initiated studies, maintaining sponsor relationships, and facilitating compliance and continuing education trainings for the specific Clinical Research Programs. These activities include the development, promotion, direction, and coordination of their assigned areas, such as research design, budget, staffing, strategy, IRB submission/management, logistics, and other supportive functions to ensure timely and high-quality deliverables.

Responsibilities

1. The Program Manager is responsible for creating and overseeing the Management Plan for this team, ensuring the timely and high-quality execution of all work breakdown structures.
2. Oversee protocol development and implementation activities across cohorts, sites, and trials to ensure milestones and deliverables are met efficiently.
3. Orient and train research staff, assist with budget development, oversee study coordination, and support general program operations.
4. Collaborate with PIs and sponsors to complete all study submissions to IRB, Cancer Center, and other regulatory bodies.
5. Track protocols through the IRB approval process, evaluate recurrent issues, and develop systems to reduce delays.
6. Conduct internal quality assurance, including monitoring and training, to ensure staff compliance with regulatory guidelines and SOPs.
7. Maintain up-to-date knowledge of Good Clinical Practice, ICH Guidelines, and SKCCC policies.
8. Lead biweekly meetings to monitor progress and ensure deliverables are on track and of high quality.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Part-time
• Job functions: Project Management and Research
• Industries: Hospitals and Health Care, Pharmaceutical Manufacturing, Biotechnology Research

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Benefits and Location

• Medical insurance
• Vision insurance
• Location: New York, United States