Senior Clinical Research Manager

The Senior Manager of Clinical Research will be responsible for leading and managing clinical trials and research studies to ensure timely completion within budget and in compliance with regulatory standards. You will oversee research teams, collaborate with cross-functional departments, and provide strategic direction for clinical research activities. Your key responsibilities will include: Clinical Trial Management: - Planning, initiating, and managing clinical research projects from start to finish. - Coordinating and overseeing the execution of clinical trials while ensuring adherence to protocols, timelines, and budgets. - Ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards. - Providing oversight on the recruitment, enrollment, and monitoring of clinical trial subjects. - Managing relationships with clinical research organizations (CROs), investigators, and external vendors. Team Leadership: - Leading and mentoring clinical research staff to ensure they are trained and performing effectively. - Assigning tasks and responsibilities to team members based on project needs. - Developing training programs and providing ongoing professional development for research teams. Regulatory Compliance: - Overseeing the preparation and submission of regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications. - Monitoring compliance with federal, state, and local regulations, as well as company policies. - Ensuring timely reporting of adverse events and meeting ethical and regulatory standards. Study Design & Protocol Development: - Working with scientific and medical teams to develop clinical trial protocols. - Ensuring protocols meet study objectives, regulatory standards, and ethical guidelines. - Evaluating feasibility and risk of proposed studies. Data Management and Reporting: - Ensuring data collection, monitoring, and analysis are conducted efficiently and accurately. - Reviewing and analyzing clinical trial data to maintain quality and integrity. - Preparing and presenting progress reports to senior leadership and stakeholders. Budget and Resource Management: - Developing and managing project budgets to ensure completion within financial constraints. - Overseeing resource allocation, including personnel, equipment, and materials. Collaboration and Communication: - Fostering communication between internal teams, external partners, and key stakeholders. - Collaborating with clinical research coordinators, data managers, and other departments for effective study execution. - Resolving any issues related to clinical trial execution and providing solutions. Continuous Improvement: - Identifying areas for process improvement in clinical trial execution and management. - Implementing best practices to optimize research efficiency and compliance. Qualifications: Education: - Bachelor's degree in Life Sciences, Clinical Research, or a 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 or supervisory role. - In-depth knowledge of clinical trial management, regulatory requirements, and GCP. Skills: - Strong project management, leadership, and organizational skills. - Excellent communication and interpersonal skills for effective interaction with stakeholders. - 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 (or equivalent).,