Clinical Country Site Lead – Southwest

This is a fully remote position, open to applicants in Arizona, +2 more states.

📋 Description

• Support and oversee Biogen's internalized flexible model by collaborating with Clinical Monitoring Leads, CRAs, FSP partners, and FSO-model partners.

• Stay updated with local knowledge of therapeutic areas and the requirements for clinical trials.

• Provide operational and scientific information at the country level for studies and programs.

• Propel global operational strategy by delivering essential study information.

• Manage relationships with investigators and research sites.

• Lead activities for local country and site selection while incorporating feedback from local stakeholders.

• Act as the primary liaison for strategic development and sponsor oversight of CRO activities.

• Supervise Sponsor Oversight Visits, audits, and inspections to ensure regulatory compliance.

• Monitor trial progress, address local challenges, and align efforts with global teams.

• Function as Lead CCSL for study or program leadership, including training and coordinating site selection activities.

• Foster relationships throughout the organization while working remotely.

⛳️ Requirements

• A Bachelor's Degree in a science-related field along with relevant experience is required.

• At least 8 years of experience in clinical research.

• Proven experience in managing clinical trial activities, particularly with sponsor oversight involving CROs and vendors.

• Knowledge of cross-functional drug development processes.

• Scientific and clinical expertise across significant therapeutic areas.

• Familiarity with ICH/GCP guidelines and local regulations.

• Strong organizational and project management capabilities.

• Proficient in relevant IT tools for virtual collaboration.

• In-depth knowledge of clinical operational activities within the local geography.

• Excellent communication skills, including proficiency in English for non-English-speaking countries.

• Willingness to travel 50–75% of the time (2–3 times per month).

• Preferred leadership and interpersonal skills.

• A collaborative approach to decision-making is preferred.

• High emotional intelligence and cultural awareness are preferred.

🏝️ Benefits

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

• Comprehensive medical, dental, vision, and life insurance coverage.

• Fitness and wellness programs, including fitness reimbursement.

• Short- and long-term disability insurance.

• A minimum of 15 days of paid vacation.

• Additional end-of-year shutdown time off (Dec 26-Dec 31).

• Up to 12 company-paid holidays plus 3 paid days off for personal significance.

• 80 hours of sick time available each calendar year.

• Paid maternity and parental leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Opportunities to participate in Employee Resource Groups.

• Access to learning, growth, and skill enhancement opportunities.