Clinical Data Manager

🕒 August 10

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 10%

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Logo of Everest Clinical Research

Everest Clinical Research

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Plan, manage, control, and perform data processing and management activities for assigned projects in compliance with Sponsors’ requirements • Lead assigned data processing and management projects using project management, data processing, and management techniques • Manage timelines and coordinate activities for assigned projects • Specify database validation checks and lead development and maintenance of standard validation checks • Define and monitor clinical trial dataflow and quality control processes according to SOPs, Good Working Practices, and unit guidelines • Train clinical trial site monitors on dataflow and QC processes • Design and review patient Case Report Forms and database schemas • Test data capture and entry screens • Validate electronically captured data • Write queries for missing data and failed range or logical checks • Lead development of a standard query library • Perform QC procedures during trials and database closure checks at study end • Train and supervise Data Entry personnel and junior data management personnel • Validate and distribute study progress status reports to internal and external study team members • Assist in resolving data coding discrepancies involving medical events, treatment procedures, and medications • Maintain documentation and prepare data management materials for final archival • Assist the corporate archivist with archiving clinical trial data and study documentation • Assist data management QA personnel with QA procedures on CRFs, database schemas, and databases

🎯 Requirements

• Bachelor’s degree in health and/or pharmaceutical sciences, physical/biological sciences, or chemistry with at least 2 years of clinical trial data capture and management experience, OR a Master’s or Ph.D degree in these fields with at least 1 year of relevant experience • In-depth understanding of clinical trial data management concepts, processes, procedures, and relevant issues • Knowledge of pharmaceutical clinical trial regulations, industry guidance, conventions, and standards • Strong leadership in clinical data management activities • Ability and desire to lead data management projects • Work remotely from a home-based office anywhere in the UK

🏖️ Benefits

• Remote work from a home-based office anywhere in the UK in accordance with the Work from Home policy • Equal opportunity and accommodations for candidates with disabilities upon request

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