Clinical Project Manager-Rheumatology / Immunology

Tigermed; United States; Hybrid; USD 90,000 - 120,000; Full time

Job summary

A global clinical research organization is seeking a Clinical Trial Project Manager to lead and manage clinical trial projects primarily in North America. The role involves ensuring successful project delivery while maintaining compliance with ICH-GCP and FDA regulations. Candidates should have a Bachelor’s degree in a relevant field and a minimum of 4 years project management experience in clinical trials, with preference for those experienced in rheumatology. Strong leadership and communication skills are essential. Relocation to North America is preferred but remote work may be considered.

Qualifications

• Minimum of 4 years of clinical trial project management experience, with at least 2 years focused on North American operations.
• Full professional proficiency in English.
• Comprehensive knowledge of ICH-GCP, FDA regulations, and the North American clinical trial landscape.
• Experience in a CRO or sponsor environment with exposure to global clinical projects is preferred.
• Willingness to relocate to North America is highly preferred; long-term remote work arrangements will also be considered.

Responsibilities

• Lead and manage global clinical trial projects with a focus on North American regions.
• Serve as the primary contact for North American sponsors and investigators.
• Develop and implement project management plans tailored for North American operations.
• Monitor project progress, quality, and compliance at North American sites.

Skills

Rheumatology experience

Leadership

Communication skills

Cross-cultural collaboration

Proficiency in Microsoft Office

Proficiency in clinical trial management systems

Education

Bachelor's degree or above in Medicine, Pharmacy, Biology, or a related field

Job description

Lead and manage global clinical trial projects with primary focus on North American regions, ensuring successful delivery within contractual scope, timeline, budget, and quality requirements. Serve as the key liaison between North American stakeholders and global project teams, promoting operational excellence and maintaining strong client relationships while adhering to ICH‑GCP, local regulations, and Tigermed SOPs.

Key Responsibilities:

• Plan and execute global clinical trials with emphasis on North American operations, including site selection, initiation, monitoring, and close‑out activities.
• Rheumatology experience required, gout rexperience prefered.
• Serve as the primary contact for North American sponsors, investigators, and regulatory stakeholders, ensuring alignment with global project objectives.
• Develop and implement comprehensive project management plans (including monitoring plans, risk management plans, and communication plans) tailored for North American operations.
• Manage cross‑functional project teams and third‑party vendors, providing guidance and support for North American project activities.
• Monitor project progress, quality, and compliance at North American sites, implementing corrective actions as needed.
• Conduct financial management and cost control for North American project components in accordance with contract requirements.
• Maintain professional communication in both English and Chinese as working languages for all project‑related correspondence and collaboration.

Qualifications:

• Bachelor’s degree or above in Medicine, Pharmacy, Biology, or a related field.
• Minimum of 4 years of clinical trial project management experience, with at least 2 years focused on North American operations.
• Full professional proficiency in English
• Comprehensive knowledge of ICH‑GCP, FDA regulations, and the North American clinical trial landscape.
• Experience in a CRO or sponsor environment with exposure to global clinical projects is preferred.
• Willingness to relocate to North America is highly preferred; long‑term remote work arrangements will also be considered.
• Strong leadership, communication, and cross‑cultural collaboration skills.
• Proficiency in Microsoft Office applications and clinical trial management systems.