Lead Data Manager

đŸ”„ 19 hours ago

🌐 Spain, Poland, +3 more countries – Remote

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⏰ Full Time

🟠 Senior

📊 Data Scientist

đŸ‘» Ghost score 10%

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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

‱ Lead end-to-end clinical data management start-up activities from protocol review through specification development, database build, testing, validation, and production go-live ‱ Review protocols to identify data collection requirements, build risks, inconsistencies, and impacts to database design or downstream processes ‱ Translate protocol requirements into study build specifications, including visit schedules, assessments, eCRFs, dosing, data collection, and edit checks ‱ Apply clinical data standards, including CDISC standards, eCRF design principles, field and variable conventions, and approved standard forms ‱ Partner with the Standards team to implement protocol-specific modifications ‱ Collaborate with Study Execution Teams, Medical Data Review, Programming, Data Management, Standards, and other stakeholders ‱ Plan and oversee sandbox testing and user acceptance testing, including defect documentation, resolution, retesting, and system-readiness confirmation ‱ Manage timelines, dependencies, deliverables, risks, and issue resolution for database go-live ‱ Assess and manage the data management impact of protocol amendments and post-go-live changes ‱ Maintain accurate data management start-up documentation in the eTMF ‱ Ensure deliverables comply with SOPs, ICH-GCP, regulatory requirements, and internal quality standards ‱ Manage day-to-day clinical data science activities and support team delivery

🎯 Requirements

‱ Bachelor's degree in life sciences, computer science, or a related discipline ‱ Extensive experience in data analysis and project leadership within a clinical research setting ‱ Strong expertise in statistical software and data visualization techniques ‱ Exceptional analytical and problem-solving skills, with a focus on translating data into actionable insights ‱ Excellent communication and leadership skills, with the ability to foster collaboration across diverse teams ‱ Willingness to travel as required (approximately 15%) ‱ 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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