Associate Clinical Data Manager – FSP, GI

🔥 3 minutes ago

🇨🇦 Canada – Remote

💵 $90k - $100k / year

⏰ Full Time

🟡 Mid-level

🧪 Clinical Research

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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 involving healthy volunteer and patient populations, multi-site studies, client management, and reduced timelines • Take accountability for DM deliverables, instruct DM study teams, review outputs, and adjust resource allocations • Ensure projects comply with protocols, global harmonized SOPs, and GCP standards • Build timelines with Project Managers and coordinate with cross-functional project leads • Lead internal data-focused project meetings and coordinate EDC Design, SAS Programming, Statistics, and PK deliverables • Identify risks and mitigations, communicate data-driven discussions, and support database lock dates • Keep Project Managers, Biometrics management, sponsor services, and sponsors informed about project progress, budgets, scope changes, and timeline impacts • Develop client relationships and review client satisfaction surveys • Track scope changes and obtain Sponsor approval • Provide leadership, mentorship, and coaching in clinical trial data management processes • Support performance evaluations and career development of team members • Learn new DM technologies and applied processes and drive process improvement • Maintain accurate work records • Reconcile clinical databases against safety, laboratory, and third-party data • Represent Data Management and Biometrics in new business opportunities • Attend and action client or internal audits and resolve issues • Promote Biometrics services to sponsors

🎯 Requirements

• University / college degree • Relevant and equivalent experience may be considered in lieu of educational requirements • Experience and/or education plus relevant work experience equating to a bachelor's degree accepted in lieu of a bachelor's degree • Fluent in English, both written and verbal • 6 to 8 years of DM experience • Minimum 1 year of direct sponsor management • Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations • Ability to adhere to project productivity metrics and timelines • Knowledge of medical terminology • 3+ years of Electronic Data Capture experience preferred • Experience handling customer concerns and managing Scope of Work and budgets preferred • Knowledge of science or a scientific background preferred • Thorough knowledge of Fortrea, organizational structure, and Standard Operating Procedures preferred

🏖️ Benefits

• Office and home-based work environment • Flexible shifts as per business requirement • Overtime and weekend work as required

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