
Chief Clinical Research Officer
3 days ago
We are seeking a seasoned Clinical Research Manager to lead and manage clinical trials and research studies, ensuring timely completion, compliance with regulatory standards, and effective collaboration with cross-functional departments.
- Clinical Trial Management
- Plan, initiate, and manage clinical research projects from start to finish, including coordinating and overseeing the execution of clinical trials, ensuring adherence to protocols, timelines, and budgets.
- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and ethical standards by preparing and submitting regulatory documentation, including Institutional Review Board (IRB) applications and clinical trial applications.
- Team Leadership
- Lead and mentor clinical research staff, ensuring they are trained and performing effectively, by developing training programs and providing ongoing professional development for research teams.
- Assign tasks and responsibilities to team members based on project needs, fostering communication between internal teams, external partners, and key stakeholders.
- Regulatory Compliance
- Oversee the preparation and submission of regulatory documentation, including IRB applications and clinical trial applications, to ensure timely reporting of adverse events and maintain study integrity.
- Monitor compliance with federal, state, and local regulations, as well as company policies, to identify areas for process improvement in clinical trial execution and management.
- Study Design & Protocol Development
- Work with scientific and medical teams to develop clinical trial protocols, evaluating feasibility and risk of proposed studies.
- Data Management and Reporting
- Ensure data collection, monitoring, and analysis are conducted efficiently and accurately, reviewing and analyzing clinical trial data to ensure quality and integrity.
- Budget and Resource Management
- Develop and manage project budgets, ensuring that clinical trials are completed within financial constraints.
Requirements:
- 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.
- Skills: Strong project management, leadership, and organizational skills; excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders; proficiency in clinical research software and data management systems; strong problem-solving and decision-making abilities.
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