EPM Scientific | Clinical Trial Manager

4 days ago


boston, United States EPM Scientific Full time
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.


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