Central Monitoring Operations Manager

🔥 0 minutes 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

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

• 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 to support trial quality and delivery • Provide site monitoring expertise to the trial team • 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 may be acceptable when complemented by solid knowledge and experience with Site Monitoring and Site Management processes and accountabilities • 3+ years of comparable previous experience • Solid knowledge and experience with Site Monitoring and Site Management processes and accountabilities • Strong communication skills in complex cross-functional matrix structures • Ability to articulate and align business strategy and plans on an ongoing basis • Active listening skills and cultural awareness • Scientific and therapeutic knowledge and operational expertise across Site Monitoring aspects in clinical trial planning and execution • Knowledge of trial complexity dimensions including protocol, patients, sites, countries, and vendors • Leadership and influence skills for addressing complex situations and coordinating and overseeing teams • Ability to support, connect, empower teams, and set priorities • Good knowledge of English language and grammar

🏖️ Benefits

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

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