Senior Clinical Data Manager

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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 and take responsibility for the development of the project documentation, system set-up, data entry and data validation procedures • Assume responsibility for all DM activities according to client quality expectations • Act as subject matter expert (SME) for DM activities in relationship meetings with Sponsors • Work directly with Sponsors to understand their requirements • Regularly review client specific processes to ensure they remain optimal for Sponsor and Fortrea • Provide guidance, mentoring and training to DM to ensure best working practices are maintained • Lead studies including a combination of healthy volunteer and patient populations • Organize and effectively prioritize workload and deliverables • Be accountable for all DM deliverables as assigned per the established timeline

🎯 Requirements

• University / college degree • 8 years of combined early or late-stage DM experience with minimum 2 years of direct sponsor management and at least 2 years technical mentoring experience • Proven experience in handling customer negotiations • Thorough knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations • Proven ability to lead by example on project strategies and achievement of department goals, objectives, and initiatives • Time management skill and ability to adhere to project productivity metrics and timelines • Ability to work in a team environment and collaborate with peers • Experience of representing DM in bid defense meetings • Good organizational ability, communication, and interpersonal skills.

🏖️ Benefits

• Professional development opportunities • Remote work options