Study Manager – FSP

• Contribute to delivering clinical studies on time, within cost and quality objectives, and maintain inspection readiness through eTMF oversight
• Drive continuous improvement initiatives and share best practices across the business
• Partner with the Study Delivery Lead on end-to-end study delivery from setup through archival
• Set up, maintain, and ensure completeness of internal systems, databases, tracking tools, and project plans
• Coordinate clinical study management activities for in-house and outsourced studies across phases and therapeutic areas
• Monitor study conduct and progress, identify, resolve, and escalate risks and issues
• Review clinical documents, including protocols and informed consent forms
• Lead development of study plans, including monitoring, vendor management, protocol deviation, risk management, and communication plans
• Facilitate meetings and interactions with regulatory, local operating company, quality assurance, monitors, CROs, and third-party vendors
• Manage vendors and provide CRO oversight, including monitoring deliverables and delegated activities
• Oversee countries, recruitment progress, data completeness and compliance, protocol deviations, risks, regulatory approvals, and import license status
• Coordinate study communications, meetings, minutes, info-spaces, newsletters, action logs, team lists, and communication plans
• Oversee delivery of clinical supplies, investigational products, and study materials
• Perform data oversight and ensure continuous inspection readiness, including eTMF setup, reviews, missing-document follow-up, and safety report dissemination
• Oversee budgets, task/change orders, expenses, system updates, agreements, and escalations
• Contribute to agile squads and potentially serve as Scrum Master
• Perform activities independently with limited instruction and support clinical trial activities across study types
• 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 and Trial Master File industry standards
• Strong project management skills, preferably with analytical/financial skills
• Good leadership skills
• Excellent verbal and written communication in English
• External service provider management skills
• Ability to manage multiple competing priorities across clinical studies
• Strong planning, time management, prioritization, analytical, problem-solving, risk-based decision-making, and attention-to-detail skills
• Expertise and seniority within the relevant area and function
• Understanding of project planning, management, finance, and accounting principles
• Excellent proficiency with Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook
• Knowledge of advanced Excel, timeline/budget tracking systems, and clinical trial management systems
• Excellent stakeholder management, communication, interpersonal, networking, influencing, facilitation, and meeting leadership skills
• Ability to work in cross-functional agile squads and across cultures and geographies
• Ability to coach and mentor study team members and adapt to a changing environment

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