Senior Clinical Data Manager

🕒 August 10

🇵🇱 Poland – 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

• Lead data management activities for assigned clinical research projects • Develop and maintain Data Management Project Plans, Data Management Plans, and Data Quality Review Plans • Serve as the primary contact for day-to-day data management activities, timelines, deliverables, and technical or procedural issues • Plan and implement data management timelines and deliverables; provide status reports and contribute to project planning and progress tracking • Assist with resource planning, client relationship management, project bids, work orders, amendments, and vendor management • Train clinical trial personnel on EDC systems, dataflow, quality control processes, and data management procedures • Perform quality-control reviews of work completed by less experienced data management personnel • Participate in project kick-off, investigators, and project management team meetings • Support client audits and regulatory inspections; follow up on audit findings • Create and maintain clinical trial Data Management Study Binders • Design and review CRFs/eCRFs, completion instructions, annotated CRFs, and source document templates • Participate in database design and EDC User Acceptance Testing • Manage post-go-live database modifications due to protocol amendments or study needs • Coordinate programming and validation of listings and summary tables • Perform third-party non-CRF data management activities • Review data and issue and resolve queries; assist investigative site personnel with query resolution • Perform Serious Adverse Event reconciliation and assist with medical coding discrepancies • Cooperate with Quality Assurance on database quality-control audits • Perform database soft-lock and hard-lock activities • Prepare final archival of data management documentation and assist with archiving clinical trial documentation

🎯 Requirements

• Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological sciences, or chemistry fields • At least 5 years of experience in pharmaceutical clinical trial data management, or at least 2 years 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 • Demonstrated leadership in clinical data management activities • Ability to lead data management projects • Ability to meet high quality standards and high levels of customer satisfaction

🏖️ Benefits

• Work from Home policy • Home-based office arrangement • Accommodations for candidates participating in any part of the recruitment and selection process

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