Senior Clinical Research Associate

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet.

That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

The Senior Clinical Research Associate is a remote position based in the United States. This role requires over 50% domestic and international travel to meet business needs.

The Senior Clinical Research Associate will play a pivotal role in establishing the new U.S. clinical monitoring operating model at EMD Serono. This position is ideal for an experienced Senior CRA or monitoring leader who is excited to help define U.S. monitoring practices, elevate site oversight standards, develop trainings and templates for future in-house CRAs. The role will be the foundational member serving as CRA for initial studies and as the pipeline grows building out the operational infrastructure as we move clinical monitoring in-house across the entire Americas portfolio.

• Contribute to building a high-performing, scalable U.S. monitoring organization aligned with global standards.
• Influence the long-term design of the U.S. insourced clinical monitoring model.
• Conduct feasibility and pre‑study activities, including site identification, evaluation, and qualification visits.
• Lead site initiation visits and train site staff on the protocol, eCRF, safety reporting, and study procedures.
• Perform routine onsite and remote monitoring to ensure data integrity, protocol adherence, and compliance with GCP, SOPs, and regulatory requirements.
• Verify source data (SDV), oversee data entry quality, and support timely query resolution.
• Monitor site performance (recruitment, data quality, timelines) and drive corrective actions when needed.
• Ensure accurate documentation, reporting of AEs/SAEs, and management of protocol deviations.
• Maintain oversight of essential documents in the ISF and TMF and ensure inspection readiness.
• Support audits and regulatory inspections, including preparation and follow‑up.
• Maintain strong communication with sites and internal study teams, including coordination and distribution of key trial communications.
• Assist with preparation and submission of regulatory documents as required.
• Participate in study meetings and contribute to the development of trial plans, materials, and operational strategies.

• Bachelor’s degree in Life Sciences (Pharmacy, Medicine, Biology, Nursing, or related field) and 5+ years of clinical research experience with strong clinical monitoring background.
• Master’s degree in Life Sciences (Pharmacy, Medicine, Biology, Nursing, or related field) and 3+ years of clinical research experience with strong clinical monitoring background.
• Clinical Research Associate / Clinical Research certification required.
• Experience across Oncology, Neurology, or Immunology.
• Demonstrated start‑to‑finish CRA experience across multiple studies.
• Strong understanding of clinical development principles, ICH‑GCP, FDA/EMA regulations, and regional requirements.

• Experience mentoring CRAs or leading monitoring activities is an…