Senior Clinical Data Manager – Sponsor Dedicated

🔥 1 minute ago

🌐 Poland, Slovakia, +5 more countries – Remote

🇵🇱 Poland – Remote 🇸🇰 Slovakia – Remote 🇪🇪 Estonia – Remote 🇧🇬 Bulgaria – Remote 🇬🇷 Greece – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Provide Clinical Data Management leadership for one or more assigned projects or indications • Take global accountability and serve as the second line of contact at project level • Lead studies involving healthy volunteer and patient populations, multi-site studies, complex protocol designs, strong client management requirements, or reduced timelines • Organize and prioritize workload and deliverables • Plan and deliver Clinical Data Management deliverables at program and project level • Manage and oversee vendor contracts, resourcing, budgets, and vendor performance • Communicate and negotiate with program-level team members • Serve as the primary point of contact for Clinical Data Management • Apply consistent Clinical Data Management processes and documentation across assigned programs • Oversee external service providers and in-house teams to deliver quality data in compliance with procedures and standards • Provide guidance on company standards, processes, systems, and expectations • Manage risks and resolve or escalate issues related to Clinical Data Management improvement or technology • Develop understanding of CDASH, SDTM, and other recognized industry standards and their impact on programming teams • Conduct lessons learned on therapeutic-area-specific data capture and standards and disseminate findings • Mentor Clinical Data Management colleagues and stakeholders • Lead project-level activities supporting study delivery

🎯 Requirements

• University/college degree in life science, pharmacy or related subject preferred, or certification in a related allied health profession from an appropriately accredited institution • 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 • Extensive experience in clinical data management • Experience leading studies in a CRO/Pharma setting • Excellent oral and written communication and presentation skills • In-depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications • Working knowledge of the relationship and regulatory obligations of the CRO industry with pharmaceutical/biotechnological companies • Ability to lead teams by example on project strategies and achievement of department goals, objectives, and initiatives • Demonstrated managerial and interpersonal skills

🏖️ Benefits

• Highly competitive compensation packages • Pension contributions • Complimentary health insurance plans • Remote working allowances • Work life balance • Flexibility in working hours • Thorough onboarding with support from a personal mentor • Permanent employment contract with Fortrea Drug Development • Career progression • Mentoring, training and personalized development planning