About the company
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regional Clinical Study Management based in the United States.
Responsibilities
- Lead regional clinical operations for assigned studies or portfolios, establishing clear goals, driving effective decision-making, and resolving escalated issues.
- Oversee regional study delivery from feasibility and startup through recruitment, execution, data collection, and closeout.
- Drive regional feasibility, country allocation, site selection, startup planning, recruitment timelines, regulatory submissions, and local adaptation of study documentation.
- Coordinate internal clinical teams, cross-functional stakeholders, and external vendors.
- Monitor regional study performance and ensure compliance with protocols, SOPs, ICH/GCP requirements, and inspection-readiness standards.
- Identify operational risks and quality concerns, implement corrective solutions, and prepare sites and teams for audits and regulatory inspections.
- Guide CRA coaching and mentoring, support monitoring quality, and ensure quality control of Trial Master File documentation.
- Support clinical data collection, data entry, query resolution, clinical supplies planning, and Clinical Study Report activities.
- Select and manage regional vendors, negotiate and monitor regional study budgets, oversee resource utilization, and coordinate investigator fees, site payments, and patient reimbursement.
- Develop and improve regional processes, tools, work instructions, and SOPs.
- Mentor junior team members, delegate responsibilities effectively, and build a high-performing clinical operations culture.
Requirements
- Bachelor’s degree in a scientific or healthcare discipline with 8+ years of progressive clinical operations experience in biotechnology, pharmaceutical, or CRO industry; or master’s degree with 6+ years of relevant experience.
- Proven leadership and management experience as a direct people manager or cross-functional clinical study leader.
- Strong experience managing regional clinical studies or portfolios across planning, startup, recruitment, execution, quality, and closeout.
- Demonstrated knowledge of clinical research operations, ICH/GCP, regulatory requirements, inspection readiness, study quality, and risk management.
- Experience managing external vendors, regional budgets, resources, investigator/site payments.
- Strong ability to lead cross-functional teams, influence stakeholders, make sound decisions, and resolve complex operational challenges.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Office and project planning applications.
Conditions
- Competitive annual base salary of $143,300–$193,300.
- Eligibility for an annual bonus plan for non-commercial roles.
- Eligibility for discretionary equity awards and employee stock purchase plan.
- Medical, dental, and vision insurance.
- 401(k) retirement plan.
- Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
- Life insurance coverage.
- Paid time off.
- Wellness benefits and programs.
- Remote work opportunity within the United States.