Clinical Trials Operations Specialist

10 uur geleden

Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

About Us

Bristol Myers Squibb is a leading biopharmaceutical company transforming patients' lives through science. Our innovative approach, diverse culture, and commitment to excellence make us an ideal place to grow your career.

Estimated Salary: $80,000 - $110,000 per year

Job Description:

We are seeking a highly motivated Clinical Trial Monitor to join our team. As a key member of our clinical operations group, you will be responsible for monitoring clinical trials to ensure their integrity, quality, and compliance with regulatory requirements.

Responsibilities:

  • Identify new potential investigators and assess their sites to ensure they have the necessary resources and capabilities to conduct clinical trials.
  • Develop strong relationships with investigators and site personnel to ensure successful trial execution.
  • Conduct initiation visits to ensure investigators and site personnel receive adequate protocol-specific training prior to site activation.
  • Review site activities and quality through on-site and off-site visits, ensuring safety and protection of study subjects.
  • Perform unblinded site monitor activities to protect the blind of the study by acting as a secondary monitoring source separate from the blinded monitor.
  • Serve as a point of contact for sites and provide trainings to ensure knowledge of protocols and procedures.
  • Manage multiple protocols across multiple therapeutic areas, requiring travel.
  • Ensure completeness and quality of data submitted from study sites, using available systems to follow site activities.
  • Motivate and influence sites to meet study objectives, including enrollment and retention goals.
  • Anticipate, identify, and proactively support sites in resolving issues as they occur, documenting and escalating serious or persistent outstanding issues.
  • Participate in regulatory compliance audits/inspections, developing and implementing corrective actions as needed.

Requirements:

  • Bachelor's degree in life sciences or equivalent, valid driver's license.
  • Clinical trial monitor experience (2-3 years) with ability to work independently.
  • Native English speaker with good verbal and written communication skills.
  • Basic to good knowledge of ICH/GCP guidelines and applicable local laws and regulations governing clinical trials.
  • Understanding of clinical landscape, practical knowledge of medical settings, and medical records management.
  • Organization and time management skills, ability to build and maintain relationships even under pressure.

Benefits:

  • Competitive salary range ($80,000-$110,000 per year)
  • Opportunities for professional growth and development
  • Diverse and inclusive culture
  • Comprehensive benefits package

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