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Title

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Clinical Trials Director

Description

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We are looking for an experienced Clinical Trials Director to lead our research and development team and oversee the planning, execution, and supervision of clinical trial activities. The person in this role will play a critical part in every phase of clinical research within pharmaceutical, biotechnology, or medical device organizations. They will ensure compliance with regulatory guidelines and maintain the quality and safety of research. The ideal candidate will have experience in clinical trial design, protocol development, budget management, and coordination with external partners. Additionally, the candidate should be skilled in managing research teams, monitoring data analysis, and preparing reports. As a Clinical Trials Director, you will be responsible for ensuring that research projects are completed on time and within budget, and that the results are prepared for submission to regulatory authorities. You will maintain effective communication with internal and external stakeholders and ensure the ethical and quality standards of the research. To succeed in this role, the candidate must possess leadership qualities, analytical thinking, and a deep understanding of the complexities of clinical research.

Responsibilities

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  • Plan and execute clinical trials
  • Develop and review research protocols
  • Prepare and manage budgets
  • Lead research teams
  • Ensure compliance with regulatory guidelines
  • Monitor data collection and analysis
  • Prepare and present research reports
  • Coordinate with external partners
  • Ensure research quality and safety
  • Meet project timelines and goals

Requirements

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  • Minimum 8 years of experience in clinical research
  • Master’s degree in biology, pharmacy, or related field
  • Knowledge of regulatory guidelines (ICH-GCP, FDA, EMA)
  • Experience in managing research teams
  • Skills in data analysis and reporting
  • Strong communication and leadership skills
  • Problem-solving abilities
  • Experience managing complex projects
  • Budget management skills
  • High ethical standards and professionalism

Potential interview questions

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  • Describe your experience managing clinical trials.
  • How do you lead a research team?
  • How do you ensure compliance with regulatory guidelines?
  • How do you manage budgets and timelines?
  • How do you ensure the quality of research?
  • How do you coordinate with external partners?
  • What was your most successful clinical trial project?
  • How do you monitor data analysis?
  • How do you prepare research reports?
  • How do you maintain research ethics?