Senior Clinical Data Manager

🔥 29 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟠 Senior

🧪 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

• Develop and maintain Data Management Project Plans and document deviations • Lead day-to-day data management activities and own deliverables for assigned projects • Manage data management timelines, deliverables, status reporting, project planning, progress tracking, and reporting • Serve as primary contact for data management communications, deliverables, out-of-scope requests, and technical or procedural issues • Assist with study-level resource planning, team member timesheet review, client relationship management, bid defense meetings, Work Orders, and Amendments • Train clinical trial personnel on EDC systems, dataflow, and quality control processes • Train new data management personnel on processes and procedures • Perform quality-control reviews of less experienced personnel’s work • Manage third-party vendor dataflow and performance • Participate in project kick-off, investigators, and project management team meetings • Support client audits and regulatory inspections and follow up on findings • Create and maintain clinical trial Data Management Study Binders • Design and review CRFs/eCRFs, completion instructions, annotated CRFs, and source document templates • Develop and maintain data validation specifications, Data Management Plans, and Data Quality Review Plans • Participate in database design and EDC User Acceptance Testing • Manage post-go-live database modifications • Coordinate programming and validation of listings and summary tables • Review data, issue and resolve queries, and assist investigative sites with query resolution • Perform Serious Adverse Event reconciliation and assist with medical coding discrepancies • Support quality control audits on assigned databases • Perform database soft-lock and hard-lock activities • Prepare final archival of data management documentation and assist the corporate archivist

🎯 Requirements

• A Bachelors’ or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields • At least 5 years of experience in pharmaceutical clinical trial data management OR at least 2 years of experience as a Clinical Data Manager II • 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 to lead data management projects and meet high quality and customer satisfaction standards

🏖️ Benefits

• Remote work from a home-based office anywhere in Taiwan in accordance with the Work from Home policy • Equal opportunity commitment • Accommodations for candidates with disabilities during recruitment and selection upon request

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