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.
