Sr. Clinical Research Associate

Advance Life-Changing Therapies: Join Our Clinical Research Team as a Sr. Clinical Research Associate

At Novo Nordisk, we are dedicated to pioneering breakthrough therapies that transform patient care and improve lives worldwide. As a Sr. Clinical Research Associate within our Clinical Operations team in Riyadh, Saudi Arabia, you will play a pivotal role in ensuring the integrity, safety, and success of our clinical trials. This is more than a job—it’s an opportunity to be the bridge between cutting-edge science and real-world impact, where your expertise directly contributes to the development of therapies that millions will rely upon.

In this dynamic and collaborative environment, you will serve as the strategic liaison between Novo Nordisk, clinical research sites, and cross-functional teams. Your responsibilities will focus on upholding the highest standards of clinical trial execution, patient safety, and regulatory compliance. By leveraging your deep understanding of ICH-GCP guidelines and Risk-Based Quality Management (RBQM), you will drive operational excellence while fostering strong partnerships with investigators and site staff. Your work will not only accelerate the development of innovative therapies but also ensure that every patient involved in our trials receives the highest level of care and protection.

Key Responsibilities

Your role will encompass a broad spectrum of critical functions, including:

• Strategic Site Oversight: Conduct comprehensive on-site and remote monitoring visits to ensure full compliance with protocols, regulatory requirements, and Novo Nordisk standards. Act as the primary advocate for quality and patient safety throughout the trial lifecycle.
• Data Integrity and Patient Safety: Monitor site data meticulously, resolve discrepancies promptly, and manage adverse events with adherence to protocols and global regulatory frameworks. Your vigilance will safeguard both the integrity of the trial data and the well-being of participants.
• Performance and Compliance Leadership: Oversee site performance metrics, including recruitment, retention, and data collection, to ensure studies stay on schedule and meet quality benchmarks. Lead site training initiatives to enhance operational efficiency and compliance awareness.
• Risk-Based Quality Management: Implement RBQM principles to proactively identify, assess, and mitigate risks that could impact trial success. Your proactive approach will minimize disruptions and optimize resource allocation.
• Stakeholder Engagement: Build and nurture collaborative relationships with investigators, site staff, and cross-functional teams. Represent Novo Nordisk’s values and commitment to excellence in every interaction, fostering a culture of trust and transparency.
• Issue Resolution and Documentation: Identify and resolve site-level challenges with agility, ensuring timely progress and data quality. Maintain accurate and up-to-date trial documentation, including the Investigator Trial Master File (ITMF), to support regulatory submissions and audits.

Join Our Innovative Research & Development Team

As part of Novo Nordisk’s Research & Development division, you will be embedded within a forward-thinking organization that merges scientific curiosity with operational precision. Our team leverages advanced technologies, including AI and human data analytics, to accelerate the development of transformative therapies. By collaborating with global project teams and clinical development centers, you will play a crucial role in advancing our pipeline from early-stage research to life-saving treatments.

In Clinical Operations, you will thrive at the intersection of innovation and rigor, where every decision impacts the future of medicine. Your contributions will ensure that our clinical trials are conducted with the utmost integrity, generating the robust data needed to bring groundbreaking therapies to patients who need them most.

What We Look For

We are seeking a Clinical Research Associate who is passionate about clinical excellence, detail-oriented, and thrives in a collaborative, quality-driven environment. The ideal candidate will bring:

• Education: A Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field. Advanced degrees are a plus.
• Experience: At least 2 years of hands-on experience in clinical trial monitoring, preferably within the pharmaceutical industry or a Contract Research Organization (CRO). Experience with Novo Nordisk or similar global organizations is highly advantageous.
• Regulatory Expertise: In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial methodologies. Familiarity with regional regulations, particularly those relevant to Saudi Arabia, is an asset.
• Communication and Leadership: Exceptional written and verbal communication skills, with the ability to engage effectively with diverse stakeholders, from site personnel to senior management. Your leadership will inspire trust and collaboration across all levels of the organization.
• Organizational Excellence: Strong project management skills, with the ability to prioritize tasks, manage multiple sites simultaneously, and maintain impeccable attention to detail. Your organizational prowess will ensure smooth trial execution and adherence to timelines.
• Technical Proficiency: Proficiency in digital clinical trial tools, including electronic data capture (EDC) systems, Clinical Trial Management Systems (CTMS), and electronic Trial Master Files (eTMF). Familiarity with other industry-standard software is a significant advantage.
• Problem-Solving and Risk Management: A proactive mindset with a track record of identifying and mitigating risks before they impact trial outcomes. Your analytical skills will drive continuous improvement in operational processes.
• Adaptability and Collaboration: Flexibility to travel as needed and the ability to work both independently and as part of a high-performing team. Your adaptability will be key in navigating the dynamic landscape of clinical research.

If you are eager to contribute to a mission that redefines healthcare and are ready to take on a role that combines scientific rigor with impactful leadership, we invite you to be part of Novo Nordisk’s journey. Help us deliver therapies that not only meet today’s challenges but also shape the future of medicine.