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Role Description

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.

Key Responsibilities

• 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.

Qualifications

• Bachelors degree in Life Sciences (Pharmacy, Medicine, Biology, Nursing, or related field) and 5+ years of experience in clinical research experience with strong clinical monitoring background.
• OR Masters degree in Life Sciences (Pharmacy, Medicine, Biology, Nursing, or related field) and 3+ years of experience in 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.

Preferred Qualifications

• Experience mentoring CRAs or leading monitoring activities is an advantage.
• Strong problem-solving and issue-resolution mindset.
• Excellent interpersonal skills with the ability to build trust with site teams and CRAs.
• Deep understanding of GCP, ICH guidelines, FDA/EMA expectations, and regional regulatory demands.
• Skilled in managing multiple sites, priorities, and timelines simultaneously.
• High attention to detail and commitment to data quality.
• Excellent written and verbal communication skills; fluency in English required.
• Proficiency with MS Office, CTMS, EDC systems, eTMF, and other clinical systems.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

Pay Range

Pay Range for this position: $123,600 - $185,400. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.