Fortrea
Fortrea
Fortrea — биофармацевтикалық және медициналық технология компанияларына қызмет көрсететін жаһандық клиникалық зерттеу ұйымы. Оның клиникалық әзірлеу қызметтері клиникалық фармакологияны, I–IV фазалардағы зерттеулерді басқаруды, реттеуші стратегияны және нарыққа қолжетімділікті қамтып, ғылыми сараптаманы деректерге негізделген тәсілдермен ұштастырады. Fortrea жасушалық және гендік терапия, онкология, жүрек-қантамыр аурулары және жұқпалы ауруларды қоса алғанда, әртүрлі бағыттардағы бағдарламаларды қолдайды. Осы арқылы компания клиенттеріне әзірлеуге қатысты негізделген шешімдер қабылдауға және ықтимал емдеу әдістерін пациенттерге жеткізу үдерісін ілгерілетуге көмектеседі.

Senior Clinical Data Manager, Oncology — Fortrea (Remote, Canada)

Lead oncology clinical-trial data management for Fortrea in a senior, remote Canada-based role. Oversee study deliverables, sponsor collaboration, database lock, compliance, and team development.

Сипаттама

  • Manage clinical-study data from start-up through database lock
  • Own project documentation, system configuration, data entry, and validation procedures
  • Serve as the data-management subject matter expert in sponsor meetings
  • Translate sponsor requirements into effective implementation plans
  • Evaluate client-specific processes and lead optimization efforts
  • Guide, mentor, and train data-management professionals
  • Oversee studies involving healthy volunteers or patients, multiple sites, complex protocols, client management, or compressed timelines
  • Serve as Study Manager for data-management deliverables, team instructions, output review, and resource planning
  • Maintain compliance with study protocols, global harmonized SOPs, and GCP standards
  • Develop timelines with Project Managers or FSP Leads and coordinate cross-functional teams
  • Lead data-management meetings and coordinate deliverables with EDC Design, SAS Programming, Statistics, and PK teams
  • Identify risks and mitigations, facilitate data-driven discussions, and support database-lock milestones
  • Track Biometrics deliverables and their effects on data-management resources and schedules
  • Keep project, Biometrics, and sponsor-services leaders updated on project, budget, scope, and timeline matters
  • Coordinate the collection and tracking of data-related information from clinical sites and vendors
  • Complete required documentation and procedures at study closeout
  • Manage client relationships, assess satisfaction feedback, execute action plans, and advance process improvement and training
  • Monitor scope changes and secure sponsor approval
  • Provide leadership, coaching, and mentorship on clinical-trial data-management practices and technical capabilities
  • Contribute to performance reviews and provide constructive career-development feedback
  • Adopt new data-management technologies and processes while supporting continuous improvement
  • Ensure service quality meets DMP and scope-of-work requirements
  • Author, review, and maintain SOPs and related documentation
  • Keep accurate and current work records
  • Reconcile clinical databases with safety, laboratory, and other third-party data
  • Represent Data Management and Biometrics in business-development opportunities and bid-defense meetings
  • Participate in client and internal audits and resolve resulting issues
  • Shape and execute directional strategy while providing technical input, training, and mentorship
  • Promote Biometrics services to sponsors
  • Perform other related duties as assigned

Талаптар

  • A university or college degree is required
  • Relevant education and work experience equivalent to a bachelor's degree may be accepted instead of a bachelor's degree
  • Relevant equivalent experience may substitute for the stated education requirement
  • English proficiency is required for speaking, writing, and reading
  • Eight years of combined early- or late-stage data-management experience
  • At least two years of direct sponsor-management experience
  • At least two years of experience providing technical mentorship
  • Demonstrated experience negotiating with customers and managing scopes of work and budgets
  • Three to five years of oncology experience
  • Strong knowledge of clinical-trial processes, data management, clinical operations, biometrics, and system applications
  • Demonstrated ability to set project strategies and deliver departmental goals, objectives, and initiatives
  • Working knowledge of CRO relationships and the regulatory responsibilities of pharmaceutical and biotechnology companies
  • Strong time-management skills and the ability to meet productivity measures and project deadlines
  • Ability to collaborate effectively in a team environment
  • Ability to mentor junior team members and provide subject-matter guidance on data-management practices
  • Experience representing Data Management in bid-defense meetings
  • Strong organizational, communication, and interpersonal skills
  • Constructive approach to problem-solving while remaining focused on deadlines
  • Preferred degree in life sciences, health sciences, information technology, or a related field
  • Preferred four or more years of Electronic Data Capture experience
  • Preferred familiarity with Fortrea, its organizational structure, and SOPs
  • Ability to work in an office or remote environment

Артықшылықтар

  • Option to work remotely
  • Travel may be required for cross-site support or training
  • Meetings may account for up to 10% of working time, with up to half of that meeting time involving overnight travel
  • Job offers reflect candidate skills and relevant experience, applicable degrees and certifications, internal equity, and market data

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