Study Manager – FSP

🔥 10 minutes ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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

🎯 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 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

🏖️ Benefits

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

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