Clinical Trial Manager II

🕒 June 5

🌐 Poland, Romania, +3 more countries – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

đŸ§Ș Clinical Research

đŸ‘» Ghost score 55%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đŸ’Œ Consulting

đŸ„ Healthcare

📩 Logistics

Consulting ‱ Healthcare ‱ Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

‱ Design and analyze clinical trials, interpreting complex medical data ‱ Oversee clinical trial management workstreams and ensure deliverables meet quality and timeline expectations ‱ Collaborate with cross-functional teams to design and implement clinical trial enrollment ‱ Develop and implement comprehensive clinical trial protocols ‱ Oversee and manage day-to-day clinical trial operations in compliance with regulatory standards ‱ Analyze and interpret clinical trial data, identify trends, and provide insights to optimize study outcomes ‱ Address challenges proactively and implement solutions for successful clinical trial execution ‱ Communicate with internal and external stakeholders to foster partnerships and facilitate smooth trial processes ‱ Manage study deliverables including study initiation, activity and delivery plans, TMF quality strategy, DCT setup, demographic and diversity plans, vendor oversight, results dissemination, investigator/CRA meetings and training, recruitment tracking, budget tracking, eTMF filing, vendor setup and management, patient engagement, safety management, protocol deviation management, and pharmacy manual ‱ Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and company SOPs ‱ Communicate study status, expectations, risks, and issues to stakeholders ‱ Operate within the study budget ‱ Understand study contribution to program/submission ‱ Develop the team and manage competing priorities

🎯 Requirements

‱ Bachelor's degree in life sciences or related discipline ‱ At least 5+ years of relevant study management experience in a pharmaceutical/scientific environment ‱ Good understanding of complex clinical development and regulatory processes ‱ Strong skills and experience in project management and tools ‱ In-depth knowledge of GCPs and ICH guidelines ‱ In-depth experience in clinical research: study management, monitoring, data management ‱ Strong performer / executor of operational tasks with strong skills and experience in study delivery ‱ Experience of working across multiple types of study designs ‱ Leadership skills promoting motivation and empowerment of others ‱ Effective communication and interpersonal skills, with the ability to collaborate across diverse global teams ‱ Detail-oriented and organized, with a track record of successfully managing multiple tasks and priorities simultaneously ‱ Good project management skills, including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available ‱ Willingness to travel as required (approximately 25%) ‱ Legal right to work in the country where the role is based

đŸ–ïž Benefits

‱ Competitive base salary and performance related incentives ‱ Health and wellbeing programmes including medical, dental, and vision coverage where applicable ‱ Retirement and pension plans ‱ Life assurance and disability coverage ‱ Employee assistance programmes and wellbeing resources ‱ Learning and development opportunities through structured training and career pathways

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