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Senior Clinical Data Manager

🔥 41 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

đźź  Senior

đź§Ş Clinical Research

đź‘» Ghost score 10%

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Logo of ICON plc

ICON plc

10,000+ employees

Founded 1990

đź’Ľ Consulting

🏥 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.

đź“‹ Description

• Serve in a support-level capacity on a Clinical Data Management team • Support the design, specifications, and development of eCRFs in adherence to company standards • Coordinate development and testing of clinical data management systems edit checks and listings/reports/tools • Support data review and discrepancy management activities • Support development of Data Management Plan documents • Work with third-party/external data vendors on data import and reconciliation processes • Review all data generated from clinical studies, including third-party/external data, SAE data, and local lab data where applicable • Oversee quality control procedures • Develop and maintain communications and working relationships with the CDM team • Manage project timelines and quality • Provide reports, status updates, feedback, and advice to key study stakeholders on data cleaning and risk identification/mitigation • Ensure CDM activities comply with Good Clinical Practice and ICH Guidelines • Apply best practices and independently offer project solutions to the study team • Support filing of eTMF documentation to maintain an inspection-ready environment • Provide backup support for the Principal Clinical Data Lead as required

🎯 Requirements

• 4+ years of Clinical Data Management experience • Ability to work under pressure demonstrating agility through effective and innovative team leadership • Robust experience with EDC (e.g. Medidata Rave) • Experience using data review tools such as elluminate, J-Review or Business Objects • Experience in Phase I/II • Neurology experience would be desirable • Extensive experience in study startup • Strong technical skills, including experience using Microsoft Excel functionality • Fluent English (oral and written) • Strong understanding of drug development and the biopharmaceutical industry • High attention to detail, including proven ability to manage multiple, competing priorities • Excellent written and oral communication skills • Legal right to work in the country where the role is based

🏖️ 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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