Clinical Operations Specialist

At uMed, we are driven by a powerful mission: transforming lives through improved access to research and healthcare. Founded by UK physician Dr. Matt Wilson, our vision is to empower healthcare institutions with cutting-edge technology to target specific patient groups for research and population health activities.

Our innovative platform takes on the heavy lifting, streamlining the identification, screening, and engagement of patients on behalf of healthcare providers. By harnessing health record data, we can precisely target patient groups, facilitating seamless communication that is automated and tailored to their needs.

At uMed, we combine cutting-edge technology with the warmth of human compassion, making a real difference in the lives of those living with diseases. If you seek purpose-driven work, meaningful challenges, and an opportunity to shape the future of healthcare, join us at uMed and be a part of something extraordinary. Together, we will create a world where research and healthcare unite for a brighter, healthier future.

Who are we looking for?

As a Clinical Research Operations specialist at uMed, you will play a pivotal role in overseeing and coordinating all aspects of clinical trials and studies. You will collaborate closely with cross-functional teams, ensuring the successful execution of clinical trials from initiation to completion. This is a unique opportunity to contribute to groundbreaking research and make a difference in the world of healthcare.

What you will be doing

• Strategic Planning: Develop and execute strategic plans for clinical trials and longitudinal cohort studies, ensuring alignment with applicable regulations and guidelines.
• Project Management: Create and maintain detailed project plans, timelines, and budgets to ensure the successful execution of trials.
• Cross-functional Collaboration: Collaborate with diverse teams, including data management, HEOR, and medical communications, to facilitate effective communication and alignment throughout the trial process.
• Site and Investigator Selection: Identify and select appropriate investigational sites and investigators, ensuring they meet study requirements and standards.
• Vendor Management: Manage relationships with external vendors, providing oversight and ensuring compliance with study protocols, regulatory requirements, and quality standards.
• Risk Mitigation: Monitor trial progress, identify potential issues or risks, and implement mitigation strategies to ensure study objectives are achieved.
• Documentation: Prepare and review study-related documents, including protocols, informed consent forms, case report forms, ethics submissions, and study reports.
• Compliance: Ensure compliance with regulatory and ethical standards, including GCP guidelines and relevant local and international regulations.
• Site Visits: Coordinate and participate in site initiation visits, monitoring visits, and study close-out activities.
• Innovation: Stay up-to-date with industry trends, best practices, and emerging technologies in clinical operations, implementing innovative approaches to optimize trial processes.

Requirements

• Background in a scientific or healthcare-related field (e.g., Life Sciences, Biotechnology, Nursing, Pharmacy).
• Proven experience in clinical operations within the biotechnology, pharmaceutical, or CRO industry.
• Strong knowledge of clinical trial management, including study start-up, monitoring, data management, and regulatory compliance in both the UK and the US.
• Strong knowledge of registries, observational and longitudinal studies.

• Thorough understanding of GCP guidelines and relevant regulatory requirements (e.g., FDA, EMA) governing clinical trials.
• Track record of successfully managing multiple clinical trials simultaneously, from initiation to completion.
• Excellent organizational skills, with the ability to prioritize tasks, manage timelines, and thrive in a fast-paced environment.
• Strong leadership abilities, with the capacity to motivate and guide cross-functional teams to achieve study objectives.
• Exceptional communication and interpersonal skills, fostering effective collaboration with internal and external stakeholders.
• Detail-oriented mindset with a strong focus on quality and compliance.
• Certifications such as Certified Clinical Research Professional (