
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.
🔥 11 minutes ago
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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.
• Lead data management on clinical studies from study start-up through database lock • Develop project documentation and establish data entry and data validation procedures and processes • Act as subject matter expert for data management activities in Sponsor relationship meetings • Understand Sponsor requirements and lead their implementation • Review client-specific processes and drive optimization • Lead studies involving healthy volunteers and patient populations, multi-site studies, complex protocols, client management, or reduced timelines • Manage data management deliverables, provide study-team instructions, review outputs, and adjust resource allocations • Ensure projects comply with protocols, global harmonized SOPs, and GCP standards • Build timelines with Project Managers or FSP Leads to meet contracted milestones • Lead data-focused internal project meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams • Identify project risks and mitigations, communicate data-driven discussions, and support database lock dates • Monitor Biometrics deliverables and their impact on data management resources and deliverables • Keep project, Biometrics, and Sponsor Services stakeholders informed of project status, budgets, scope changes, and timeline impacts • Coordinate receipt and inventory of clinical-site and vendor data-related information • Ensure project-completion documentation and procedures are completed • Maintain client relationships, review satisfaction surveys, and implement action plans, process improvements, and team training • Track scope changes and obtain Sponsor approval • Provide leadership, mentorship, coaching, and technical guidance to data management study teams • Support performance evaluations and career development of team members • Learn new data management technologies and applied processes and contribute to process improvement • Ensure service and quality meet DMP and scope-of-work specifications • Write, review, and update SOPs and associated documents • Maintain accurate work records • Reconcile clinical databases against safety, laboratory, and other third-party data • Use local laboratory systems and batch data-load facilities where appropriate • Represent Data Management and Biometrics in new business opportunities and bid defense meetings • Attend and resolve client or internal audit issues • Develop and implement directional strategy and roll out training and mentorship • Promote Biometrics services to Sponsors • Perform other duties assigned by management
• University / college degree • Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • English speaking, writing, and reading required • 8 years of combined early or late-stage DM experience • Minimum 2 years of direct sponsor management experience • At least 2 years of technical mentoring experience • Proven experience handling customer negotiations • Experience managing Scope of Work and budgets • Thorough knowledge of clinical trial processes, data management, clinical operations, biometrics, and supporting system applications • Ability to lead project strategies and achieve department goals, objectives, and initiatives • Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical/biotechnological companies • Time management skills and ability to adhere to project productivity metrics and timelines • Ability to work in a team environment and collaborate with peers • Ability to mentor junior department members and provide SME guidance on DM practices • Experience representing DM in bid defense meetings and providing innovative client solutions • Good organizational, communication, and interpersonal skills • Constructive problem-solving attitude while deadline focused • Preferred: university/college degree in life sciences, health sciences, information technology, or related subjects • Preferred: four or more years of Electronic Data Capture experience • Preferred: thorough knowledge of Fortrea, its organizational structure, and SOPs
• Potential travel for cross-site support or training needs, meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay • Remote-based work option • Employer consideration of applicable degrees/certifications, internal equity, market data, skills, and prior relevant experience in job offers
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