Associate Director, Regional Clinical Study Management

Job Description:

• Accountable for regional study or portfolio delivery with inspection-readiness quality, within agreed timelines and budget
• Act as regional lead for one or multiple studies across an indication or program
• Lead the regional clinical operations team, including external regional partners
• Serve as point of escalation for regional study or portfolio issues
• Develop regional tools, work instructions, and SOPs
• Drive regional trial and portfolio deliverables
• Lead planning and management of assigned clinical studies from feasibility through closeout
• Generate and maintain regional study start-up and recruitment timelines
• Drive regional trial feasibility, country allocation, and site selection
• Provide regional input on global study plans
• Coordinate local adaptations of global study documents and regulatory/EC/IRB submissions
• Ensure regional and country information in study systems and tools is current
• Coach and mentor CRAs; review and sign off monitoring reports as needed
• Ensure country and site-level Trial Master File creation, maintenance, and quality control
• Provide input on regional drug inventories, local drug labels, comparator drug regulatory approval, and reimbursement status
• Manage regional data collection, data entry, and query resolution
• Support Clinical Study Report planning and execution
• Monitor compliance with protocols, SOPs, ICH/GCP, and applicable regulations
• Maintain inspection readiness and prepare sites for audits and inspections
• Identify regional risks, implement solutions, and share best practices
• Lead improvements to study efficiency and quality
• Select and manage regional study vendors
• Manage and negotiate regional study budgets
• Coordinate investigator fees, site payments, and patient travel reimbursement
• Monitor regional resource utilization
• Ensure clinical team competencies meet company requirements
• Mentor junior team members and support development plans

Requirements:

• Bachelor's degree in a scientific or healthcare discipline
• 8+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry
• Preferably master's degree in a scientific or healthcare discipline and 6+ years of progressive experience in clinical operations within biotech, pharmaceutical or CRO industry
• Proficiency with MS Office and project planning applications
• Solid leadership and management experience either as a direct line manager or cross-functional team lead
• Strong written and verbal communication skills
• Sound judgment and discretion in matters of significance
• Ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Excellent interpersonal and organizational skills
• Ability to influence and lead
• Willingness to travel as required by business need

Benefits:

• Annual bonus plan eligibility for non-commercial roles
• Incentive compensation plan eligibility for commercial roles
• Discretionary equity awards
• Voluntary participation in the Employee Stock Purchase Plan
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness benefits
• Reasonable accommodation in the job application process