Study Manager – FSP

• Contribute to delivering clinical studies on time, within cost and quality objectives, while ensuring inspection readiness
• Drive continuous improvement initiatives and share best practices across the business
• Partner with the Study Delivery Lead on end-to-end operational study delivery from setup through archival
• Set up, maintain, and ensure completeness of internal systems, databases, tracking tools, and project plans
• Work cross-functionally with internal and external partners on clinical study management activities across phases and therapeutic areas
• Monitor study conduct and progress and identify, resolve, and escalate delivery risks and issues
• Review key clinical documents, including protocols and informed consent forms
• Lead development of study plans, including monitoring, vendor management, protocol deviation management, risk management, and communication plans
• Facilitate and maintain meetings and interactions with regulatory, local operating company, quality assurance, CRO, and third-party vendor partners
• Manage vendors and provide CRO oversight, including overseeing deliverables and delegated activities
• Provide country oversight, tracking recruitment, data completeness, compliance, protocol deviations, risks, regulatory approvals, and import license status
• Coordinate study-related activities and manage study team communications, meetings, minutes, info-spaces, newsletters, action logs, team lists, and communication plans
• Oversee delivery of clinical supplies, investigational products, and study materials; communicate risks and propose solutions
• Provide data oversight and maintain eTMF completeness and quality for inspection readiness
• Manage budget oversight, including task/change orders, expenses, system updates, agreements, and issue escalation
• Contribute to agile squads and potentially serve as Scrum Master
• Perform study activities independently across study types with limited instructions from the Study Delivery Lead
• Mentor less experienced colleagues

• University degree or equivalent, preferably in medical or biological science or a discipline associated with clinical studies
• At least 3+ years of relevant work experience in a pharmaceutical/scientific environment
• Knowledge of clinical trials and the drug development process
• Excellent knowledge of ICH-GCP, clinical study delivery processes, regulations, operational best practices, and industry standards
• Familiarity with key systems used in clinical trial delivery
• Experience using an industry-accepted Trial Master File standard
• Strong project management skills, preferably including analytical/financial skills
• Good leadership skills
• Excellent verbal and written communication in English
• Excellent communication and relationship-building skills, including external service provider management
• Knowledge of applicable clinical trial regulatory requirements, including GCP and ICH guidelines
• Ability to manage multiple competing priorities with planning, time management, and prioritization skills
• Ability to think independently, analyze and solve problems systematically and creatively, and take a risk-based approach
• Confirmed expertise and seniority within the area and function
• Logical/analytical thinking, pattern and outlier identification, quality mindset, critical sense, and attention to detail
• Effective training and mentoring skills
• Very good understanding of project planning and management principles
• Knowledge of project finance and accounting principles, including budgets, invoices, cross-charges, and expense reports
• Excellent comprehension of Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook
• Knowledge of advanced Excel, timelines/budget tracking systems, and clinical trial management systems
• Excellent stakeholder management and communication skills, including oral and written communication
• Outstanding interpersonal skills
• Excellent networking and stakeholder-influence capabilities
• Ability to facilitate and lead cross-functional meetings, challenge inefficient ways of working, and act as a mediator
• Results-driven and efficient; motivated and dynamic personality
• Ability to work in a changing and challenging environment and coach study team members
• Ability to work in cross-functional squads using an agile model
• Team spirit and ability to work across cultures and geographies with awareness and understanding of cultural differences

• Fully remote work arrangement
• Standard Monday–Friday work schedule