We are seeking a dedicated and experienced Clinical Operations Manager to join our dynamic clinical trials team. The ideal candidate will have a strong background in clinical research and trials management, with the ability to oversee and manage the execution of clinical studies. As a Clinical Manager, you will ensure the clinical trials are conducted in compliance with regulatory requirements, within budget, and on time. You will work closely with cross-functional teams and serve as a liaison between sponsors, clinical research organizations (CROs), and investigators. Key Responsibilities: Clinical Trial Management: Lead the planning, execution, and monitoring of clinical trials from initiation to completion, ensuring timelines and milestones are met. Protocol Adherence: Oversee the implementation and execution of clinical trial protocols and ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and other regulatory requirements. Vendor and Stakeholder Management: Coordinate with external partners, CROs, and clinical sites, ensuring all parties are aligned with study objectives and timelines. Risk Management: Proactively identify and address any issues or risks that may arise during clinical trials, implementing corrective actions as necessary. Budget and Resource Management: Develop and manage clinical trial budgets, ensuring efficient use of resources and adherence to financial constraints. Data Integrity: Ensure proper data collection and reporting processes are followed, facilitating high-quality, accurate data. Regulatory Compliance: Ensure all regulatory documentation is prepared, submitted, and tracked in accordance with industry standards. Reporting and Documentation: Provide regular updates and reports on the status of clinical trials, including progress, deviations, and any challenges to senior leadership. Continuous Improvement: Contribute to the development and enhancement of clinical trial processes, standard operating procedures (SOPs), and best practices. Qualifications: Education: Bachelor’s degree in Life Sciences, Nursing, or a related field (Master’s or advanced degree is a plus). Experience: Minimum of 10 years of experience in clinical trial management, with at least 2 years in a leadership role. Knowledge: Deep understanding of clinical trial protocols, GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.). Skills: Strong project management, organizational, and leadership skills. Communication: Excellent verbal and written communication skills, with the ability to collaborate effectively with internal teams, external stakeholders, and clinical sites. Problem-Solving: Ability to anticipate and address challenges proactively and effectively. Software Proficiency: Familiarity with clinical trial management systems (CTMS), electronic data capture (EDC) systems, and Microsoft Office Suite. Seniority level Mid-Senior level Employment type Full-time Job function Research Industries Pharmaceutical Manufacturing #J-18808-Ljbffr