Clinical Country Site Lead (Southwest)
About The Position
The Country Clinical Site Lead (CCSL) is a strategic, externally facing role that provides critical local operational and scientific expertise to support global clinical development strategies. Acting as a key liaison between investigators, research sites, CROs, affiliate teams, and global study teams, the CCSL helps ensure the successful delivery of clinical trials while maintaining a strong focus on quality, patient safety, and operational excellence. The CCSL brings valuable country-specific insights to global development programs, ensuring local opportunities and needs are incorporated into study planning and execution. The role also serves as an escalation point for site-related issues, including patient safety and data integrity concerns, and supports effective resolution through collaboration with internal stakeholders. Working within Biogen's Internalized Flexible Model, the CCSL partners closely with Clinical Site Engagement and Clinical Monitoring Operations teams, including Clinical Monitoring Leads (CMLs), Site Managers, and FSP partners, to promote seamless collaboration and drive successful country-level study execution.
Requirements
- Bachelors Degree with a science background and experience required; advanced/graduate degree preferred
- 8+ years of clinical research experience including experience managing clinical trial activities, especially sponsor oversight with CROs/vendors.
- Understanding of cross-functional drug development processes and scientific/clinical knowledge across key therapeutic areas.
- Familiarity with ICH/GCP and 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, including English proficiency in non-English speaking countries.
- Willingness to travel 50-75% (2-3x/month)
Nice To Haves
- Leadership skills and interpersonal skills.
- Collaborative decision-making approach.
- High emotional intelligence and cultural awareness.
Responsibilities
- Support and manage the internalized flexible model, including effective collaboration (and potential management) with Clinical Monitoring Leads (CMLs), CRAs, and properly support communication with FSP partners, and ensure clear ways of working at the country level. Additionally, support and collaborate with partners working under the FSO model.
- Maintain up-to-date local knowledge of therapeutic areas researched by Biogen and clinical trial requirements.
- Engage in operational and scientific discussions to provide country-level information on studies and programs.
- Drive global operational strategy by delivering study information.
- Manage investigator and site relationships to foster collaboration and satisfaction.
- Lead local activities for country and site selection to incorporate feedback from local stakeholders.
- Serve as the primary contact for strategic development and execution of sponsor oversight of CRO activities.
- Oversee activities like Sponsor Oversight Visits, audits, and inspections to ensure compliance with regulations.
- Monitor trial progress, address local challenges, and align with global teams effectively.
- Act as Lead CCSL for study or program leadership, including training and coordination of site selection activities.
- Build relationships across the organization while operating remotely.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
