Senior Clinical Data Manager – Medical Device

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🕒 May 14

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Data Management leadership on studies • Responsible for the development of project documentation, system set-up, data entry, and validation procedures • Assume responsibility for all DM activities from study start-up to database lock • Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors • Work directly with Sponsors to understand their requirements • Provide guidance, mentoring, and training to DM staff • Organize and effectively prioritize workload and deliverables • Ensure all projects are carried out in strict accordance with protocols, SOPs, and GCPs • Build timelines to meet contracted milestones • Provide DM project team leadership and accountability • Maintain awareness of other functional group deliverables to support risk and mitigation strategies • Develop and maintain client relationships and review client satisfaction surveys

🎯 Requirements

• University / college degree • Experience and/or education plus relevant work experience • Fluent in English, both verbal and written • 5-7 years of clinical DM experience • Minimum of 3 years of hands-one clinical EDC system experience • Thorough knowledge of the clinical trial process, DM, clinical operations, biometrics, and system applications to support operations • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotech or medical device 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 members of the department

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development • Potential travel for cross-site support or training needs