Senior Clinical Research Manager

As the Senior Manager of Clinical Research, you will play a crucial role in leading and managing clinical trials and research studies. Your responsibilities will include: - **Clinical Trial Management:** - Plan, initiate, and oversee clinical research projects, ensuring adherence to protocols, timelines, and budgets. - Maintain compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards. - Supervise the recruitment, enrolment, and monitoring of clinical trial subjects. - Manage relationships with clinical research organizations (CROs), investigators, and external vendors. - **Team Leadership:** - Lead and mentor clinical research staff, assigning tasks based on project needs. - Provide training programs and professional development for the research teams. - **Regulatory Compliance:** - Oversee the preparation and submission of regulatory documentation. - Monitor compliance with regulations and company policies. - Ensure timely reporting of adverse events and ethical standards. - **Study Design & Protocol Development:** - Collaborate with scientific and medical teams to develop clinical trial protocols. - Evaluate feasibility and risk of proposed studies. - **Data Management and Reporting:** - Ensure efficient data collection, monitoring, and analysis. - Review and analyze clinical trial data for quality and integrity. - Present progress reports to senior leadership and stakeholders. - **Budget and Resource Management:** - Develop and manage project budgets. - Oversee resource allocation, including personnel, equipment, and materials. - **Collaboration and Communication:** - Foster communication between internal teams, external partners, and stakeholders. - Collaborate with various departments for effective study execution. - **Continuous Improvement:** - Identify areas for process improvement in clinical trial execution. - Implement best practices for research efficiency and compliance. **Qualifications:** - **Education:** - Bachelor's degree in Life Sciences, Clinical Research, or related field (Master's or higher preferred). - **Experience:** - 8 to 18 years of experience in clinical research, with at least 2-3 years in a managerial role. - **Skills:** - Strong project management, leadership, and organizational skills. - Excellent communication and interpersonal skills. - Proficiency in clinical research software and data management systems. - Strong problem-solving and decision-making abilities. - **Certifications:** - Clinical Research Coordinator (CRC) or Clinical Research Associate (CRA) certification preferred. This role offers you the opportunity to lead and manage clinical research activities effectively, ensuring compliance, quality, and efficiency in clinical trials and research studies.,