Regional Clinical Study Manager

Job Description:

• Accountable for regional study delivery with inspection readiness quality, within agreed timelines and budget
• Act as regional lead for multiple studies across an indication or program
• Lead regional clinical operations teams and external regional partners
• Serve as escalation point for regional study issues
• Align regional deliverables with overall study goals
• Develop regional tools, work instructions and SOPs
• Lead regional planning and management of clinical studies from feasibility through closeout
• Manage study start-up and recruitment timelines and track progress
• Drive trial feasibility, country allocation and site selection
• Coordinate local adaptations of global study documents and regulatory/ethics submissions
• Maintain regional and country information in study systems
• Collaborate with CRAs to ensure study execution and review monitoring reports
• Ensure regional and country-level Trial Master File creation, maintenance and quality control
• Provide input on clinical supplies, drug inventories, labels and comparator drug status
• Manage regional data collection, data entry and query resolution
• Support Clinical Study Report planning and execution
• Monitor compliance with protocol, SOPs, ICH/GCP and applicable regulations
• Ensure inspection readiness and prepare sites for audits and inspections
• Lead quality improvements and share best practices
• Select and manage regional vendors
• Manage regional study budgets
• Address investigator fees, site payments and patient travel reimbursement
• Manage regional resource needs and utilization
• Provide performance feedback and mentor junior team members

Requirements:

• Bachelor’s Degree in a scientific or healthcare discipline required
• Higher Degree preferred
• 6 or more years of progressive experience in clinical research within biotech, pharma or CRO industry
• Proven experience in clinical research, including relevant experience as team lead in clinical functions
• Experience as CRA preferred
• MS Office proficiency
• Project Planning Applications proficiency
• Relevant clinical operations experience may qualify for exceptions to the degree requirement
• Travel might be required as per business need

Benefits:

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