Senior Clinical Data Manager, Oncology

🔥 2 minutes ago

🇨🇦 Canada – Remote

💵 $110k - $120k / 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 • Develop project documentation and data entry and validation procedures and processes • Assume responsibility for all data management activities within timelines and budgets • Act as subject matter expert in sponsor relationship meetings • Understand sponsor requirements and lead their implementation • Review client-specific processes and drive optimization • Lead studies involving healthy volunteer and patient populations, multi-site studies, complex protocols, client management, or reduced timelines • Serve as Study Manager accountable for data management deliverables and study team output • Build timelines with Project Managers or FSP Leads and coordinate with cross-functional project teams • Lead internal data-focused project meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK • Identify risks and mitigations and communicate data-driven discussions to achieve database lock dates • Coordinate receipt and inventory of clinical and vendor data and complete project documentation • Develop and maintain client relationships, review satisfaction surveys, and implement action plans • Track scope changes and obtain sponsor approval • Provide leadership, mentorship, coaching, training, and performance feedback to data management staff • Learn new data management technologies and support process improvements • Ensure services and quality meet DMP and scope-of-work specifications • Write, review, and update SOPs and associated 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 resolve client or internal audit issues • Support directional strategy and promote Biometrics services to sponsors • Perform other 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 accepted in lieu of educational requirements • English speaking, writing, and reading required • 8 years of combined early- or late-stage data management experience • Minimum 2 years of direct sponsor management experience • At least 2 years of technical mentoring experience • Proven experience handling customer negotiations • Experience managing Scope of Work and budgets • Oncology experience • Thorough knowledge of clinical trial processes, data management, clinical operations, biometrics, and 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 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 data management practices • Experience representing data management 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

🏖️ Benefits

• Medical insurance • Dental insurance • Vision insurance • Life insurance • Short-term disability (STD) • Long-term disability (LTD) • 401(K) • Paid time off (PTO) or Flexible time off (FTO) • Company bonus where applicable • Comprehensive benefits eligibility for regular full-time or part-time employees working 20 or more hours per week

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