Senior Clinical Research Associate at EMD Serono Research & Development Institute

Billerica, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

185400.0

Posted On

08 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Monitoring, Site Oversight, Training Development, Protocol Adherence, Data Integrity, GCP Compliance, Source Data Verification, Query Resolution, AE/SAE Reporting, TMF Management, Audit Support, Regulatory Inspections, Communication, Operational Strategy, Problem-Solving, Issue Resolution

Industry

Pharmaceutical Manufacturing

Description

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. Location: The Senior Clinical Research Associate is a remote position based in the United States. This role requires over 50% domestic and internation travel to meet business needs. Your Role: 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. Who You Are Minimum 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. 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. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

This role is pivotal in establishing the new U.S. clinical monitoring operating model, involving defining monitoring practices, elevating site oversight standards, and developing training materials for future in-house CRAs. Key duties include conducting site visits, performing routine monitoring to ensure compliance and data integrity, and managing site performance.