Clinical Trial Manager

Job Title: Clinical Trial Manager (CTM) Location: Boston, Massachusetts Department: Clinical Operations Reports to: Director of Clinical Operations Job Summary: The Clinical Trial Manager (CTM) is responsible for the planning, implementation, and management of clinical trials focused on inflammation-related therapies. This role ensures that clinical trials are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and company SOPs. The CTM will work closely with cross-functional teams, including clinical research associates (CRAs), data managers, and biostatisticians, to ensure the successful execution of clinical studies. Key Responsibilities: Trial Planning and Management: Develop and manage clinical trial timelines, budgets, and resources. Oversee the selection and management of clinical trial sites. Ensure all trial activities are conducted in accordance with the protocol, GCP, and regulatory requirements. Vendor and CRO Management: Select and manage Contract Research Organizations (CROs) and other vendors. Monitor vendor performance to ensure quality and compliance with contractual obligations. Regulatory Compliance: Prepare and submit regulatory documents to ethics committees and regulatory authorities. Ensure all trial documentation is complete, accurate, and maintained in accordance with regulatory requirements. Team Leadership and Collaboration: Lead and mentor clinical research associates (CRAs) and other trial staff. Collaborate with cross-functional teams to ensure the successful execution of clinical trials. Data Management and Reporting: Oversee data collection, management, and analysis. Prepare and present trial progress reports to senior management. Qualifications: Bachelor's degree in life sciences, nursing, or a related field (advanced degree preferred). Minimum of 5 years of experience in clinical trial management. Strong knowledge of GCP, ICH guidelines, and regulatory requirements. Excellent organizational, communication, and leadership skills. Ability to manage multiple projects and priorities simultaneously. Proficiency in clinical trial management systems (CTMS) and other relevant software. Preferred Qualifications: Experience in inflammation or immunology therapeutic areas. Certification in clinical research (e.g., ACRP, SOCRA). Benefits: Competitive benefits package including 401k match, PTO, bonus, and two holiday breaks. Opportunities for professional development and career advancement. Collaborative and innovative work environment.