Central Monitoring Operations Manager

🔥 1 hour ago

🇧🇬 Bulgaria – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

⚙️ Operations

👻 Ghost score 10%

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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

• Identify and characterize issues and trends in operational and patient clinical trial data using analytical or statistical tools • Evaluate issues and develop findings based on analyzed data • Communicate issues and potential risks to project team members for follow-up action • Participate in risk mitigation strategies • Own site monitoring strategy and oversight, including authoring risk assessments and monitoring plans • Ensure effective sponsor oversight, trend analysis, and signal detection • Provide site monitoring expertise to the trial team and lead implementation of monitoring and oversight approaches • Oversee planning, execution, and issue management of site monitoring activities across all R/OPUs • Ensure compliance with protocol, ICH-GCP, and regulatory requirements • Maintain inspection readiness • Safeguard patient safety, data integrity, and trial outcomes through monitoring oversight

🎯 Requirements

• University or comparable degree in life sciences or related field, OR several years of equivalent professional education acceptable when complemented by solid knowledge and experience with Site Monitoring and Site Management processes and accountabilities • 3+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Strong communication skills in complex cross-functional matrix structures • Demonstrated Accountability Agility Intrapreneurship (AAI) approach and skills • Ability to articulate and align business strategy/plan on an ongoing basis • Active listening skills and cultural awareness • Scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution • Experience with trial complexity involving protocols, patients, sites, countries, and vendors • Leadership skills for addressing complex situations and coordinating and overseeing teams • Ability to support, connect, and empower teams and set priorities • Good knowledge of English language and grammar

🏖️ Benefits

• Fully remote work arrangement

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