Senior Clinical Data Manager – Sponsor Dedicated

🔥 0 minutes ago

🇵🇱 Poland – 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

• Provides CDM leadership for one or more assigned projects or indications, depending on project size and scale • Leads studies involving healthy volunteer and patient populations, multi-site studies, complex protocol designs, client management, or reduced timelines • Demonstrates leadership and operational expertise in strategic planning and delivery of CDM deliverables at program and/or project level • Manages and oversees vendor contracts, resourcing, budgets, and vendor performance for assigned programs and projects • Communicates and negotiates with program-level team members • Serves as the primary point of contact for Clinical Data Management • Provides oversight and expertise of external service providers or in-house teams to deliver quality data in compliance with study model procedures and standards • Leads proactive risk management and issue resolution/escalation related to Clinical Data Management improvement or technology • Develops understanding of CDASH, SDTM, and other recognized industry standards and their impact on programming teams to ensure consistency of program-level standards

🎯 Requirements

• University/college degree (life science, pharmacy or related subject preferred) • 8 years of combined early or late-stage DM experience • Minimum 2 years of direct sponsor management experience • At least 2 years technical mentoring experience • Extensive experience in clinical data management • Experience leading studies in a CRO/Pharma setting • Understanding of RECIST criteria • 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

• Highly competitive compensation packages • Pension contributions • Complimentary health insurance plans • Remote working allowances • A genuine work life balance • Flexibility in working hours • Thorough onboarding with support from a personal mentor • Mentoring, training and personalized development planning