Senior Clinical Data Manager

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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

• Lead clinical data management studies from study start-up through database lock • Take responsibility for project documentation, system set-up, data entry, and data validation procedures and processes • Act as subject matter expert for data management activities in Sponsor relationship meetings • Understand Sponsor requirements and lead their implementation • Provide guidance, mentoring, coaching, and training to data management staff • Manage data management deliverables, study team instructions, output reviews, and resource allocations • Ensure projects comply with protocols, global harmonized SOPs, and GCP standards • Build timelines with Project Managers or FSP Leads to meet contracted milestones • Lead data-focused internal project team meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams • Identify risks and mitigations, communicate data-driven discussions, and support database lock dates • Keep project, Biometrics management, and Sponsor services teams informed of project progress, budget status, scope changes, and timeline impacts • Coordinate receipt and inventory of clinical site and vendor data • Develop client relationships, review client satisfaction surveys, and implement action plans and process improvements • Track scope changes and obtain Sponsor approval • Provide technical input into strategy, SOPs, training, and mentorship • Reconcile clinical databases against safety, laboratory, and third-party data • Utilize local laboratory systems and batch data load facilities • Represent Data Management in new business and bid defense opportunities • Attend and resolve client or internal audit issues • Maintain accurate work records and perform other duties assigned by management

🎯 Requirements

• University / college degree; relevant work experience and/or education equating to a bachelor's degree accepted in lieu • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • 8 years of combined early- or late-stage data management experience • Minimum 2 years of direct Sponsor management experience • Minimum 2 years of technical mentoring experience • Experience handling customer negotiations and managing Scope of Work and budgets • Thorough knowledge of clinical trial processes, data management, clinical operations, Biometrics, and supporting system applications • Ability to lead project strategies and achieve department goals, objectives, and initiatives • Working knowledge of CRO industry relationships and regulatory obligations with pharmaceutical/biotechnological companies • Time management skills and ability to meet productivity metrics and timelines • Ability to collaborate in a team environment • Ability to mentor junior department members and provide SME guidance on data management practices • Experience representing Data Management in bid defense meetings • Good organizational, communication, and interpersonal skills • Constructive problem-solving attitude and ability to work under deadlines, time demands, incomplete information, or unexpected events • English speaking, writing, and reading required • Preferred: life sciences, health sciences, information technology, or related university/college degree • Preferred: four or more years of Electronic Data Capture experience • Preferred: knowledge of Fortrea organization and SOPs • Potential travel for cross-site support or training, meetings up to 10% of the time

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • STD/LTD insurance • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable