Associate Clinical Data Manager – FSP

🔥 20 minutes ago

🌐 Romania, Poland, +4 more countries – Remote

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

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

👻 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

• Responsible for the full cycle of Clinical Data Management queries • Cooperate with Clinical Data Managers, Data Coordinators, Statistical Programmers and others • Assist and lead operations alongside Senior CDM • Develop project documentation, system setup, data validation processes and procedures assigned to junior staff • Work with Senior CDM to build study milestone timelines and follow study timelines for on-time deliverables • Assist or lead internal and external DM meetings • Manage proactively risks and resolve or escalate issues connected to Clinical Data Management improvement or technology • Develop understanding of CDASH and SDTM or other recognized industry standards and their impact on programming teams • Specialize in TA-specific data capture and standards, conduct lessons learned and disseminate them across the organization • May act as a team leader or mentor Clinical Data Management colleagues and stakeholders on operational processes • Lead project-level activities consistent with current or previous experience in support of study delivery

🎯 Requirements

• University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) • Additional relevant work experience will be considered in lieu of formal qualifications • Experience in clinical data management as a Lead DM or Senior CDA or similar within early phase trials at CRO/pharma level • 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 to support operations • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical / biotechnological companies

🏖️ Benefits

• Various local benefits such as pension contributions • Complimentary health insurance plans • Remote working allowances • Genuine work life balance • Flexibility in working hours • Thorough onboarding with support from a personal mentor • Permanent employment contract with Fortrea Drug Development • Rewarding career progression • Mentoring, training and personalized development planning