Project Manager - Autoimmune Disease

Emerald Clinical; North Carolina; On-site; USD 150,000 - 175,000; Full time

Job summary

Emerald Clinical Trials is a global, full‑service CRO seeking an experienced Project Manager to join our growing team in the USA. This home‑based role leads global and regional clinical trials across multiple therapeutic areas, with emphasis on autoimmune studies.

The ideal candidate has 5–7 years of project management experience in clinical research, strong autoimmune trial background, and proven budget oversight, contract management and leadership in a fast‑paced, global environment.

Qualifications

• 5–7 years of project management experience in clinical research.
• Strong autoimmune disease clinical trial experience is required.
• Experience in clinical site management and CRA roles is preferred.
• Budget management, forecasting, and contract oversight.
• Excellent communication and leadership skills.
• Solid knowledge of ICH-GCP and regulatory requirements (FDA, TGA, EMA).
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat).

Responsibilities

• Lead assigned clinical projects ensuring successful execution.
• Serve as primary point of contact for clients, vendors, and internal stakeholders.
• Oversee study management activities: site selection, initiation, monitoring, closeout.
• Develop and maintain study timelines, budgets, and plans.
• Mitigate risks and address challenges to keep projects on track.
• Ensure compliance with ICH-GCP and regulatory guidelines.
• Manage vendor relationships and study contracts.
• Mentor junior project team members.
• Support proposal development and business growth initiatives.
• Participate in project team meetings to ensure alignment.

Skills

Project management

Autoimmune trials

Budget management

ICH-GCP knowledge

Leadership

MS Office

Stakeholder management

Education

Bachelor's degree or higher in relevant field

Job description

At Emerald Clinical Trials, we are a global, full-service Contract Research Organization (CRO) with a rich heritage in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific expertise and operational excellence, supporting biopharmaceutical, medical device, and diagnostic customers across all trial phases, from registration to post-marketing.

Our therapeutic expertise spans renal, cardiometabolic, and oncology - areas where we make a significant impact on improving global health.

At the heart of our success is our ability to combine global reach with local knowledge. Our on-the-ground teams work closely with local communities, building trust and ensuring diverse, representative patient recruitment. By prioritizing people, we deliver better engagement, more accurate data, and faster results—bringing therapies to patients in need.

About The Role

We are seeking an experienced Project Manager to join our growing team in USA. This is a home-based role, offering flexibility while providing the opportunity to lead global and regional clinical trials across multiple therapeutic areas. The ideal candidate will have experience managing Autoimmune related studies and a strong background in project leadership, financial oversight, and strategic trial execution.

Your Responsibilities

• Provide strong, independent leadership for assigned clinical projects, ensuring successful execution.
• Serve as the primary point of contact for clients, vendors, and internal stakeholders.
• Oversee study management activities, including site selection, initiation, monitoring, and closeout.
• Develop and maintain study timelines, budgets, and project plans, ensuring adherence to scope.
• Mitigate risks and proactively address challenges to keep projects on track.
• Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs.
• Manage vendor relationships and study-specific contracts.
• Provide mentorship and guidance to junior project team members.
• Support proposal development, bid defense meetings, and business growth initiatives.
• Participate in internal and external project team meetings to ensure alignment and success.

About You

To be successful in this role, you will have:

• 5–7 years of project management experience in clinical research, preferably in a CRO or pharmaceutical environment.
• Strong Autoimmune disease clinical trial experience is required.
• Prior experience in clinical site management and CRA roles is preferred.
• Proven expertise in budget management, forecasting, and contract oversight.
• A proactive, solutions-oriented mindset with excellent communication and leadership skills.
• Strong knowledge of ICH-GCP and regulatory requirements (FDA, TGA, EMA, etc.).
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Adobe Acrobat).
• Ability to manage multiple priorities in a fast-paced, global environment.
• A degree in a relevant scientific, healthcare, or project management field.

Why Join Us?

At our core, Emerald Clinical Trials is committed to transforming clinical research by putting people first - both patients and our employees. By joining our team, you’ll be part of a global network of passionate professionals working together to deliver better research and outcomes for millions worldwide.

Here’s What Makes Us Stand Out

• Purpose-Driven Work: You’ll contribute to clinical trials that genuinely improve lives, with a focus on therapies in renal, cardiometabolic, and oncology.
• Global Reach, Local Expertise: Our teams connect with local communities, building trust and meaningful engagement for every trial.
• Collaboration and Innovation: Work in a culture that values diverse perspectives and creative solutions to solve global health challenges.

What We Offer

We understand that great work happens when people feel valued and supported. That’s why we provide:

• Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
• Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
• Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
• Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
• Global Opportunities: Be part of a company with international reach, offering you exposure to diverse projects and clients.

We are an equal-opportunity employer and encourage applications from all qualified candidates.

The expected salary range for this position is $150,000 - $175,000 per year, depending on experience and qualifications.