We are seeking an experienced Project Manager / Senior Clinical Research Manager (PM/SCRM) to provide oversight and quality assurance support for an ongoing hospital-based study in the US. This senior role requires a strong background in clinical operations, with responsibilities focused on reviewing site and CRO performance, identifying risks, and preparing corrective action plans to ensure study delivery.

Key Responsibilities

• Oversee performance of approx. 20 hospital-based sites across the US.
• Provide quality oversight of CRO activities, ensuring compliance with protocol, ICH/GCP, and regulatory requirements.
• Conduct a combination of onsite visits and remote reviews to evaluate study progress.
• Identify operational issues and develop corrective and preventive action plans (CAPA).
• Serve as a liaison between sponsor, CRO, and site teams.
• Contribute to study governance and oversight reporting.

Requirements

• Strong background as a CRA/CTM, with extensive clinical trial monitoring and management experience.
• Experience in hospital-based studies; prior exposure to oncology and infectious diseases is highly desirable.
• Demonstrated expertise in quality assurance and oversight of clinical operations.
• Excellent communication and organizational skills, with ability to work independently across multiple stakeholders.

Assignment Details

• FTE level: 0.5–1.0 depending on availability.
• Contract length: 6 months.
• Start date: As soon as practical.
• Travel: Site visits required (frequency and scope to be agreed; remote oversight possible for some activities).

What We Offer

• Competitive compensation and benefits.
• Opportunity to work on impactful studies in a collaborative international environment.

About TFS

Our journey began more than 25 years ago in Lund, Sweden. Today, TFS operates in 17 countries across Europe, North America, Asia-Pacific, and the Middle East, delivering tailored clinical development solutions to our partners.

Our core values — Trust, Quality, Flexibility, and Passion — define who we are and guide how we work. They are the foundation of our culture and our success.