Clinical Data Manager

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🕒 April 29

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

💊 Pharmaceuticals

🧬 Biotechnology

🤝 B2B

Pharmaceuticals • Biotechnology • B2B

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. • Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques. • Manage timelines and coordinate activities for assigned projects. • Specify database validation checks for assigned studies. • Lead efforts in developing and maintaining standard database validation checks. • Define and monitor clinical trial data flow and quality control (QC) processes. • Perform clinical trial site monitors’ training on data flow and QC processes. • Write clear queries on missing data and data points failing pre-defined range checks. • Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study. • Train and supervise Data Entry personnel and junior data management personnel on study procedures.

🎯 Requirements

• A Bachelors’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields with at least 2 years experience in clinical trial data capture and management • In-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards. • Strong leadership in clinical data management activities and a desire to excel in leading data management projects.

🏖️ Benefits

• flexible work arrangements