Associate Clinical Data Manager

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🔥 4 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $70k - $80k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

📊 Data Scientist

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Lead clinical data management studies from study start-up through database lock • Develop project documentation, system setup, data entry, and data validation procedures • Manage all data management deliverables, timelines, budgets, and resource allocations • Provide instruction, leadership, mentorship, and coaching to DM study teams • Ensure projects comply with protocols, global harmonized SOPs, and GCP standards • Build timelines with Project Managers and coordinate deliverables across EDC Design, SAS Programming, Statistics, and PK • Lead data-focused internal project meetings and identify project risks and mitigations • Keep Project Managers, Biometrics management, and sponsor services informed of project status, budget, scope, and timeline impacts • Develop and maintain client relationships and review client satisfaction surveys • Track scope changes and obtain Sponsor approval with the Project Manager • Reconcile clinical databases against safety, laboratory, and other third-party data • Utilize local laboratory systems and batch data load facilities • Represent Data Management and Biometrics in new business opportunities • Attend and action client or internal audits and resolve issues • Address client comments and promote Biometrics services to sponsors

🎯 Requirements

• University / college degree; relevant and equivalent experience may be accepted in lieu of educational requirements • Experience and/or education plus relevant work experience equating to a bachelor's degree accepted in lieu of a bachelor’s degree • Fluent in English, written and verbal • 6 to 8 years of Data Management experience • Minimum 1 year of direct sponsor management experience • Knowledge of clinical trial processes, Data Management, clinical operations, Biometrics, and supporting system applications • Ability to manage customer concerns, Scope of Work, and budgets preferred • Time management skills and ability to meet project productivity metrics and timelines • Ability to work in a team environment and collaborate with peers • Organizational, communication, interpersonal, and team-working skills • Knowledge of medical terminology • University / college degree in life sciences, health sciences, information technology, or related subjects preferred • Scientific background preferred • Thorough knowledge of Fortrea, its organizational structure, and SOPs • 3+ years of Electronic Data Capture experience • Willingness to work overtime and weekends as required • Willingness to work flexible shifts according to business requirements

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable • Flexible shifts as per business requirement