Clinical Country Site Lead (Southwest)
New
B
BiogenBiotechnology
Remote, USAFull-TimeManager
Salary$134,000.00-$179,000.00
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Job Details
- Languages
- English
- Experience
- 8+ years of clinical research experience
- Required Skills
- Project Management
Requirements
- Bachelors Degree with a science background (advanced/graduate degree preferred).
- 8+ years of clinical research experience, including managing clinical trial activities and sponsor oversight with CROs/vendors.
- Solid understanding of cross-functional drug development processes.
- Scientific and clinical knowledge across key therapeutic areas.
- Familiarity with ICH/GCP guidelines and country regulations.
- Strong organizational and project management skills.
- Proficiency in IT tools for virtual teamwork.
- Excellent knowledge of local clinical operational activities.
- Strong communication skills with English proficiency.
- Willingness to travel 50-75% of the time (2-3x/month).
Responsibilities
- Manage the internalized flexible model by collaborating with Clinical Monitoring Leads (CMLs), CRAs, and FSP partners.
- Maintain up-to-date knowledge of therapeutic areas and clinical trial requirements.
- Engage in operational and scientific discussions to provide country-level study insights.
- Manage investigator and site relationships to ensure collaboration and satisfaction.
- Lead local activities for country and site selection by incorporating local stakeholder feedback.
- Serve as the primary contact for strategic development and sponsor oversight of CRO activities.
- Oversee Sponsor Oversight Visits, audits, and inspections to ensure regulatory compliance.
- Monitor trial progress and address local challenges in alignment with global teams.
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