• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Clinical Trial Manager

Job Number: 35080

Location:

Job Description

The Clinical Trial Manager leads Clinical Research Associates to ensure the successful execution of clinical studies, maintaining accuracy, quality, and regulatory compliance. This role involves collaborating with cross-functional teams, overseeing study milestones, planning, organizing, tracking clinical monitoring, administering trials, training site staff, and managing study closeout activities.

Responsibilities

  • Manage and mentor the CRA team, oversee study monitoring and compliance, and monitor site trends and metrics.
  • Guide study document development and implement team efficiency improvements.
  • Maintain clinical site relationships, coordinate site monitoring and training, and develop CRA training plans.
  • Support and evaluate co-monitoring visits, assist with site identification and meetings, and create monitoring plans and reports.
  • Develop site training and presentations, support site audits and resolve findings, and ensure compliance with regulations and policies.
  • Maintain a positive and proactive approach.

Required Skills

  • Bachelor’s or Master’s in a science-related field.
  • Over 4 years of clinical research experience, including project management.
  • Thorough understanding of clinical study processes and ICH-GCP.
  • Strong knowledge of clinical trial regulations (e.g., US FDA, EMEA).
  • Experience managing and mentoring teams.
  • Preferably experienced in biotech, pharmaceutical, and/or medical device industries.
  • Prior vocational experience (Co-Ops, Internships, Fellowships) a plus.
  • Highly effective interpersonal, problem-solving, and analytical skills.
  • Ability to manage large, complex trials and communicate cross-functionally.
  • Proven track record in dynamic, high-growth organizations.
  • Innovative, creative problem solver with an entrepreneurial spirit.
  • Experience leading fast-paced projects with urgency and quality.
  • Hands-on experience and expertise.
  • Team player and collaborator in small environments.
  • Highly organized, detail-oriented, and quality-focused.
  • Excellent verbal and written communication skills.
  • High professionalism, confidence, personal values, and ethical standards.
  • Up to 30% travel required.

 

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