Director, Clinical Data Management

Job not on LinkedIn

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $180k - $210k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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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

• Establish and control clinical data operations to provide complete, valid, safe, and secure databases meeting corporate and regulatory requirements • Develop and manage clinical data management budgets and resource plans • Assess and control resource and budget utilization • Achieve divisional objectives within the agreed budget • Manage client project portfolios with other corporate executives • Maintain strong client relations • Assist with project bids for new projects • Ensure timely availability, completeness, validity, and effectiveness of clinical data capture instruments and databases • Plan and direct integration of CRF design, database definition and administration, data entry, data management, storage, QC, and QA • Integrate Clinical Data Management with Quality Assurance and Compliance, Project Management, Clinical Operations, Biostatistics, Statistical Programming, and Medical Writing • Perform competitive benchmarking of clinical data operations • Establish and maintain data management guidelines and procedures aligned with industry good practices • Investigate, establish, and implement new systems, standards, and procedures • Recruit, train, motivate, and develop staff • Complete annual and semi-annual performance reviews • Plan, implement, and oversee staff training and development • Plan, manage, and control resources to fulfill unit and corporate missions, goals, and policies

🎯 Requirements

• A M.Sc. in Computer Science, Biostatistics or Mathematics, or Life Sciences • Lower academic degrees acceptable with proven abilities and the level of expertise required for the job • At least 15 years’ of Clinical Data Management experience • Minimum of 3 years line management experience • Comprehensive knowledge of systems, programs, and operations required to collect, store, perform QC and QA, and process clinical data • Knowledge of international standards including 21 CFR Part 11 and ICH guidelines • Experience leading a team and exceptional people management skills • Ability to interact successfully and communicate effectively with personnel at all organizational levels • Experience designing and implementing Standard Operating Procedures for Clinical Data Management • Experience with client relationship management and developing future business preferred • Excellent analytical and creative problem-solving skills • Excellent client relationship management skills • Commitment to process improvement • Ability to develop and implement strategic operations and processes • Technical expertise and ability to manage high-profile projects • Ability to communicate effectively orally and in writing • Experience leading or participating in evaluation and implementation of new systems, processes, and standards • Experience leading and directing development and implementation of new standards and procedures

🏖️ Benefits

• Remote work from a home-based office anywhere in the United States in accordance with the Work from Home policy • Accommodations for candidates participating in any part of the recruitment and selection process, upon request • Equal opportunity employment and protections for veterans and individuals with disabilities