Global Study Manager – FSP

🔥 6 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

• Deliver clinical operations activities for assigned studies 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 • Accountable for operational delivery of clinical studies on time, within quality standards and budget, and according to scientific requirements • Support decision-making and lead study teams to achieve study deliverables • Lead or deliver study initiation meetings, clinical study activity plans, study delivery plans, TMF quality strategy documents, DCT setup, vendor oversight plans, investigator/CRA meetings and training, recruitment tracking, budget tracking, eTMF filing, vendor setup and management, and safety management plans • Identify, oversee, and mitigate study risks • Ensure stakeholder communication 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 investigator meetings and other study-related meetings • Lead quality efforts to ensure protocol compliance and continual inspection readiness • Oversee activities of countries participating in the study

🎯 Requirements

• Bachelor’s degree in life sciences or related discipline • At least 5+ years of relevant global study management experience • In-depth experience in clinical research, including study management, monitoring, and data management • Previous in-depth oncology experience • End-to-end global clinical study management experience across NA, EMEA, APAC, LATAM, China, and Japan; Africa experience is an asset • Proven experience from study feasibility through Clinical Study Report (CSR) • At least Phase II and Phase III experience; Phase I, PI, and PIV experience is an asset • Proven cross-functional leadership experience and ability to drive internal and external meetings • Ability to contribute to clinical protocols, informed consent forms, study plans, clinical study risk management, and clinical systems • Strong clinical budget management experience • Strong vendor management experience, including CROs • Experience with competent authority inspections, including FDA, EMA, MHRA, and PMDA; involvement in pivotal drug-registration studies is an asset • Fluent English sufficient to negotiate and discuss complex clinical topics and present status to upper management • Excellent stakeholder management and oral and written communication skills • Outstanding interpersonal skills • Leadership skills promoting motivation and empowerment • Strong understanding of clinical study, drug development, sample management, associated processes, and quality requirements, including ICH/GCP guidelines and SOPs • Good project management skills, including scope, budget, timeline, resource planning and management, and associated tools

🏖️ Benefits

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

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