Study Manager – FSP

🔥 12 hours ago

🌐 Bulgaria, Romania, +3 more countries – Remote

🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇵🇱 Poland – Remote 🇭🇺 Hungary – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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