Senior Clinical Data Manager – Oncology

🔥 10 minutes ago

🇨🇦 Canada – Remote

💵 $130k - $140k / year

⏰ Full Time

🟠 Senior

🧪 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 data management on clinical studies from study start-up through database lock • Take responsibility for project documentation, system setup, 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 implementation • Review client-specific processes and drive optimization • Provide guidance, mentoring, and training to data management staff • Lead studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, client management, or reduced timelines • Act as Study Manager accountable for data management deliverables, study team instructions, output review, and resource allocation • Ensure projects comply with protocols, global harmonized SOPs, and GCP standards • Build timelines with Project Managers or FSP Leads and coordinate with cross-functional project teams • Lead data-focused internal project 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 • Monitor Biometrics deliverables and impacts on data management resources and timelines • Keep project, Biometrics, and sponsor services management informed of project, budget, scope, and timeline information • Coordinate receipt and inventory of data-related information from clinical sites and vendors • Ensure documentation and procedures are completed at project closeout • Maintain client relationships, review satisfaction surveys, implement action plans, and drive process improvements and training • Track scope changes and obtain Sponsor approval • Provide leadership, mentorship, and coaching in clinical trial data management processes and technical capabilities • Support performance evaluations and provide constructive career-development feedback • Learn new data management technologies and applied processes and support process improvement • Ensure service and quality meet DMP and scope-of-work specifications • Write, review, and update SOPs and related documents • Maintain accurate work records • Reconcile clinical databases against safety, laboratory, and other third-party data • Represent Data Management and Biometrics in new business opportunities and bid defense meetings • Attend and address client or internal audits and resolve issues • Develop and implement directional strategy, technical input, training, and mentorship • Promote Biometrics services to Sponsors • Perform other related duties as assigned

🎯 Requirements

• University / college degree • Experience and/or education plus relevant work experience, equating to a bachelor's degree accepted in lieu of a bachelor's degree • Relevant and equivalent experience may be considered in lieu of educational requirements • Speaking/Writing/Reading: English required • 8 years of combined early or late-stage DM experience • Minimum 2 years of direct sponsor management experience • At least 2 years of technical mentoring experience • Proven experience handling customer negotiations and managing Scope of Work and budgets • 3-5 years of Oncology experience required • Thorough knowledge of clinical trial process, data management, clinical operations, biometrics, and system applications • Proven 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 adhere to project productivity metrics and timelines • Ability to work in a team environment and collaborate with peers • Ability to mentor junior department members and provide SME guidance on DM practices • Experience representing DM in bid defense meetings • Good organizational, communication, and interpersonal skills • Constructive problem-solving attitude while deadline focused • Preferred: University / college degree in life sciences, health sciences, information technology, or related subjects • Preferred: Four or more years of Electronic Data Capture experience • Preferred: Thorough knowledge of Fortrea, its organizational structure, and SOPs • Ability to work in an office or remote-based environment

🏖️ Benefits

• Remote-based work option • Potential travel for cross-site support or training needs • Meetings up to 10% of the time, with up to 50% of that time requiring an overnight stay • All job offers based on candidate skills and prior relevant experience, applicable degrees/certifications, internal equity, and market data