Lead, Clinical Research Associate

Added
1 minute ago
Type
Full time
Salary
Salary not provided

Related skills

regulatory requirements 21 cfr part 11 good clinical practice trial master file site initiation visits

📋 Description

  • Lead and develop a team of Clinical Research Associates and contractors.
  • Oversee monitoring and site management across clinical trials.
  • Ensure adherence to policies, procedures, regulations, and quality standards.
  • Coordinate resource allocation and manage workloads.
  • Collaborate with sponsors, project managers, investigators, vendors, and teams to maintain momentum.
  • Drive process improvements and maintain trial quality and timelines.

🎯 Requirements

  • Bachelor’s degree in biomedical or life sciences or equivalent experience.
  • Minimum 5 years in clinical operations within CRO/pharma; at least 3 years on-site monitoring.
  • Demonstrated people-management experience.
  • Strong knowledge of Good Clinical Practice and 21 CFR Part 11.
  • Hands-on experience with trial activities: site visits, monitoring, and trial master file
  • Excellent English communication and strong organizational skills.

🎁 Benefits

  • Leadership development and opportunities to grow a Clinical Research team.
  • Exposure to diverse trials, sponsors, and regulatory activities.
  • Opportunities to influence monitoring strategy and process improvements.
  • Collaboration in a supportive, integrity-driven environment.
  • Professional development and knowledge-sharing opportunities.
  • Travel opportunities for site visits and meetings.
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