Global Study Manager – FSP, PACT/MAP Experience

🔥 16 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 12%

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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

• Deliver clinical operation activities from study initiation through study archiving • Generate accelerated delivery plans focused on upper-quartile performance and deliver against target or stretch thresholds with quality • Work with the Global Study Lead on end-to-end clinical study delivery • Ensure operational delivery of global clinical studies on time, within quality standards, budget, company standards, and scientific requirements • Support rapid decision-making and lead study teams to achieve overall study deliverables • Deliver study initiation meetings, clinical study activity plans, study delivery plans, TMF quality strategy documents, DCT setup, vendor oversight plans, investigator/CRA meeting setup and training, recruitment tracking, budget tracking, eTMF filing, vendor setup and management, and safety management plans • Identify, oversee, and mitigate study risks • Manage stakeholder communications regarding study status, expectations, risks, and issues • Operate within the study budget • Lead empowered matrix teams • Provide operational input into protocols, informed consent forms, and other key study documents • Lead and conduct investigator meetings and other study-related meetings • Lead quality efforts to ensure protocol compliance and continual inspection readiness • Oversee activities of participating countries

🎯 Requirements

• Bachelor’s degree in life sciences or related discipline • At least 5+ years of relevant global study management experience • Previous experience with PACT/MAP • In-depth experience in clinical research, including study management, monitoring, and data management • End-to-end global clinical study management experience across NA, EMEA, APAC, LATAM, China, and Japan; Africa is an asset • Proven experience from study feasibility through CSR • At least Phase II and Phase III experience; Phase I and Phase IV experience is an asset • Proven cross-functional leadership experience and ability to lead internal and external meetings • Ability to contribute to clinical protocols, ICFs, study plans, clinical study risk management, and clinical systems • Strong clinical budget management experience • Strong vendor management experience, including CROs • Exposure to competent authority inspections, including FDA, EMA, MHRA, and PMDA • Fluent English, with ability to negotiate, discuss complex clinical topics, adapt messaging, and present clear status updates • Excellent stakeholder management and oral and written communication skills • Outstanding interpersonal skills • Leadership skills, including motivating and empowering others • Strong understanding of clinical studies, drug development, sample management, associated processes, quality requirements, ICH/GCP guidelines, and SOPs • Good project management skills, including scope, budget, timeline, resource planning and management, and associated tools

🏖️ Benefits

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

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