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BiogenPosted 3 weeks ago

Clinical Country Site Lead (Southwest)

$134,000–$179,000 year

Remote

Full TimeSenior LevelLarge

Job Summary

Manage the internalized flexible model by collaborating with Clinical Monitoring Leads, CRAs, and FSP partners to ensure clear operational workflows at the country level. Lead local activities for site selection, oversee Sponsor Oversight Visits, audits, and inspections to maintain regulatory compliance, and serve as the primary escalation point for site-related issues including patient safety and data integrity. Drive global operational strategy by delivering study information, engaging in operational and scientific discussions to incorporate local insights into study planning, and managing investigator relationships to foster collaboration and satisfaction. Monitor trial progress, address local challenges, and align effectively with global teams while building strong relationships across the organization in a remote setting.

Required Qualifications

  • Bachelors Degree with a science background
  • 8+ years of clinical research experience
  • Experience managing clinical trial activities
  • Experience with sponsor oversight with CROs/vendors
  • Understanding of cross-functional drug development processes
  • Scientific/clinical knowledge across key therapeutic areas
  • Familiarity with ICH/GCP
  • Familiarity with country regulations
  • Strong organizational and project management skills
  • Proficiency in relevant IT tools for virtual teamwork
  • Excellent knowledge of clinical operational activities in local geography
  • Strong communication skills
  • English proficiency in non-English speaking countries
  • Willingness to travel 50-75% (2-3x/month)
  • Bachelor's degree with a science background and experience

Desired Qualifications

  • Advanced/graduate degree
  • Leadership skills
  • Interpersonal skills
  • Collaborative decision-making approach
  • High emotional intelligence
  • Cultural awareness

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