Clinical Research Program Manager (Site Management)

$80,000 - $120,000/Yr

Chdi - Princeton, NJ

Full-time - Mid Level

Remote - Princeton, NJ

About the position

The Clinical Research Program Manager (CPM) at CHDI is responsible for managing a portfolio of clinical study sites focused on Huntington's disease research. This role involves ensuring compliance with study protocols, regulatory requirements, and internal guidelines while fostering collaboration among site staff, investigators, and external partners. The CPM will oversee various aspects of clinical studies, including training site staff, monitoring site activities, and managing project documentation, all aimed at advancing the organization's mission to develop effective treatments for Huntington's disease.

Responsibilities

• Independently manage a portfolio of 20+ clinical study sites, ensuring adherence to study protocol, regulatory requirements, and internal SOPs.
• Foster strong relationships with site staff, investigators, and key stakeholders to promote collaboration and support site success.
• Conduct regular check-ins with sites to assess performance, address concerns, and provide support as needed.
• Monitor site activities from study activation through closeout, identifying and resolving any issues that may arise.
• Ensure all site staff are appropriately trained on study protocols, procedures, and data entry requirements; facilitate training sessions as needed.
• Maintain up-to-date knowledge of each site's Institutional Review Board (IRB) requirements and ensure compliance with ethical standards.
• Assist sites with data entry and resolution of queries to ensure accurate and complete data collection.
• Serve as the primary point of contact for site inquiries and escalate issues as needed to ensure timely resolution.
• Develop and review project descriptions, project budgets, and associated contracts to assure compliance with Foundation policies.
• Manage and drive various aspects of select clinical studies and process improvement projects.
• Proactively identify issues and facilitate discussion of potential solutions that can be implemented by the project team.
• Track and report on progress of clinical projects to the extended project team and management as appropriate.

Requirements

• Bachelor's or Master's degree in life sciences, healthcare, project management/business, or related field.
• Experience in pharmaceutical industry/biotech/CRO/academic experience in clinical research project/trial management including budgeting, contracting and study execution is a plus.
• Proactive, creative problem-solving skills and openness to innovative solutions.
• High attention to detail and commitment to quality work.
• Demonstrated ability to multitask, prioritize responsibilities, and work effectively in a fast-paced environment.
• Excellent communication skills.
• Proficiency in Microsoft applications: Excel, PowerPoint, and Word.

Nice-to-haves

• Knowledge of site management and monitoring processes, and quality assurance procedures.
• Knowledge of, and experience applying Good Clinical Practice (GCP) and ICH Guidelines.
• Advanced skills using Excel to develop tracking and budget/invoicing spreadsheets; proficiency in MS Project.
• Certification in clinical research (e.g., CCRA, CCRP).
• Experience with ICF negotiations and regulatory document management.
• Experience working on CNS clinical research or drug development.

Benefits

• Hybrid work environment
• Competitive salary range of $80,000 - $120,000 per year
• Opportunity to work on impactful research in Huntington's disease