Senior Clinical Data Manager

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Everest Clinical Research

WebsiteLinkedInAll Job Openings

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