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: 0.51.0 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.