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.