Regional Clinical Study Manager

Job Description:

• Accountable for regional study delivery with inspection-ready quality, agreed timelines and budget
• Lead the regional clinical operations team and oversee external regional partners
• Act as escalation point for regional study issues
• Align regional deliverables with overall study goals
• Lead regional operations meetings and represent the regional study team at internal and cross-functional meetings
• Plan and manage assigned clinical studies from feasibility through regional closeout
• Generate, manage and maintain regional study start-up and recruitment timelines
• Drive trial feasibility, country allocation and site selection with relevant stakeholders
• Provide regional input on global study plans
• Coordinate local adaptations of global study documents and support timely regulatory and EC/IRB submissions
• Ensure study submissions in assigned countries in collaboration with study start-up and regulatory teams
• Maintain regional and country information in study systems and tools
• Collaborate with CRAs on site execution and review/sign off monitoring reports
• Ensure country and site-level Trial Master Files are created, maintained and quality-checked
• Provide input on regional drug inventories, local drug labels, comparator drug approvals and reimbursement status
• Manage regional trial data collection, data entry and query resolution
• Support Clinical Study Report planning and execution
• Handle escalated site issues and monitor compliance with protocols, SOPs, ICH/GCP and regulations
• Ensure regional inspection readiness and implement solutions to study issues
• Prepare sites for audits and inspections and drive responses to findings
• Share learnings and best practices across teams
• Lead improvements and contribute to work instructions and SOPs
• Select and manage regional study vendors with sourcing
• Manage regional study budgets
• Coordinate investigator fees, site payments and patient travel reimbursement
• Identify regional resource needs and contingency plans
• Monitor regional resource utilization
• Provide performance feedback and mentor junior team members as needed

Requirements:

• 4 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 is preferred
• Bachelor’s Degree in a scientific or healthcare discipline required; higher degree preferred
• Exceptions might be made for candidates with relevant clinical operations experience
• MS Office proficiency
• Project Planning Applications proficiency
• Knowledge of clinical study delivery, clinical operations, study start-up, recruitment, feasibility, country allocation, site selection, regulatory submissions, TMF management, data collection, query resolution, ICH/GCP, SOPs and applicable regulations
• Ability 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
• Employee Stock Purchase Plan
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• FSA/HSA
• Life insurance
• Paid Time Off
• Wellness benefits
• Reasonable accommodation for applicants with disabilities