Global Study Manager – FSP, PACT/MAP experience

🔥 1 minute ago

🇬🇧 United Kingdom – 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

• Deliver clinical operational 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 in consultation with the Global Study Lead for end-to-end clinical study delivery • Lead operational delivery of global clinical studies on time, within quality, 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 study budgets • Lead empowered matrix teams • Provide operational input into protocols, informed consent forms, and other key study documents • Lead and conduct investigator and study-related meetings • Lead quality efforts for 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 experience is an asset • Proven experience from study feasibility through Clinical Study Report (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 drive internal and external meetings • Ability to contribute to clinical protocols, informed consent forms, and study plans • Expertise in 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 in English, with ability to negotiate and discuss complex topics and present clear status updates to upper management • Excellent stakeholder management and oral and written communication skills • Outstanding interpersonal skills • Leadership skills that promote motivation and empowerment • 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, timelines, resource planning and management, and associated tools

🏖️ Benefits

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