Local Clinical Trial Manager – FSP

🔥 3 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 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 final clinical study deliverables within contracted timelines • Lead local, within-country clinical study teams and provide matrix leadership and project management • Coordinate between central and country study teams • Support study feasibility and site selection; lead site selection and oversee local study performance • Deliver studies on time, within budget, and to quality expectations under protocol, regulatory, and ICH-GCP requirements • Develop and maintain country study plans, budgets, resource estimates, milestones, timelines, quality plans, and risk plans • Monitor recruitment targets, patient recruitment cycle times, data quality, and audit/inspection readiness • Troubleshoot and resolve issues affecting country study delivery • Manage site supplies and local supply inventory • Ensure trial master file completeness, study-system accuracy, reporting, and monitoring of risk and performance indicators • Develop country/site risk assessments, mitigation plans, and escalation processes • Review and approve monitoring visit reports and ensure monitoring activities are completed • Manage study budgets, site payments, vendor selection, contracts, negotiations, and local vendor oversight • Develop study documents, plans, manuals, informed consent forms, translations, and regulatory submissions • Coordinate submissions and communications with regulatory authorities and ethics committees • Maintain knowledge of study compounds, protocols, disease areas, local treatment guidelines, and healthcare systems • Assist with audits and inspections and provide responses and follow-up • Train in-country staff and investigator sites and coordinate local study meetings • Manage safety issues and safety report handling, including SAE reporting • Collaborate with medical, regulatory, legal, finance, vendor, site, and other study stakeholders • Travel as needed for the role

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 1+ years of experience in a CTM role • Previous experience in oncology advantageous • Experience in site monitoring • Equivalent combination of education, training, and/or directly related experience may be considered • Strong understanding of clinical study, drug development, sample management, and associated quality requirements • Strong project management skills and ability to work in a matrix environment • Knowledge of country local regulations and, if required, other countries' regulations, ICH-GCP guidelines, and written standards • Good English written and verbal communication skills • Proven negotiation skills • Strong computer skills and willingness to learn new systems • Ability to travel for project-related activities as required • Ability to work effectively in a remote environment • Ability to understand and apply digital innovations to clinical trials • Conceptual, analytical, and strategic thinking, including data literacy • Problem-solving and conflict-resolution skills

🏖️ Benefits

• Health and wellbeing support • Accessibility services and accommodations for job seekers with disabilities • Remote work arrangement