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Fortrea
Fortrea
Asistență medicalăBiotehnologieProduse farmaceutice
Fortrea este o organizație globală de cercetare clinică ce oferă servicii companiilor biofarmaceutice și de tehnologie medicală. Serviciile sale de dezvoltare clinică includ farmacologia clinică, gestionarea studiilor din faza I până în faza IV, strategia de reglementare și accesul pe piață, combinând expertiza științifică cu abordări bazate pe date. Fortrea sprijină programe în domenii precum terapiile celulare și genice, oncologia, bolile cardiovasculare și bolile infecțioase, ajutând clienții să ia decizii informate privind dezvoltarea și să avanseze tratamente potențiale către pacienți.
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Associate Manager, Clinical Data Management (Hybrid)

Lead clinical data management activities across complex studies, coordinating trial data, vendors, cross-functional teams, and database lock preparation. Support Fortrea’s clinical research services through delivery oversight, client collaboration, and process improvement.

USStatele Unite ale Americii
85.000 $ – 95.000 $ / an
HibridNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Lead clinical studies involving healthy volunteers and patients, including multi-site programs, client coordination, and accelerated timelines
  • Own clinical data management deliverables, study-team guidance, output review, and resource planning
  • Ensure study work follows protocols, harmonized global SOPs, and GCP requirements
  • Create project timelines with Project Managers and cross-functional stakeholders
  • Chair data-focused project meetings and coordinate deliverables across EDC Design, SAS Programming, Statistics, and PK teams
  • Assess risks, define mitigations, facilitate data-driven discussions, and support database lock milestones
  • Monitor Biometrics deliverables and advise on their effect on data management resources and commitments
  • Keep Project Managers, Biometrics leadership, sponsor services, and sponsors updated on project activity
  • Build client relationships and review client satisfaction feedback
  • Track scope changes and secure Sponsor approval in partnership with the Project Manager
  • Lead, mentor, and coach colleagues in clinical trial data management practices
  • Contribute to performance reviews and provide actionable career development feedback
  • Adopt new data management technologies and processes while identifying opportunities for improvement
  • Maintain complete and accurate work records
  • Reconcile clinical databases with safety, laboratory, and third-party data
  • Represent Data Management and Biometrics in new business activities
  • Participate in client and internal audits, take required actions, and resolve findings
  • Promote Biometrics services to sponsors
  • Conduct EDC database user acceptance testing and review data validation listings
  • Reconcile external data, coordinate with vendors, and resolve data queries
  • Clean EDC data, issue queries, maintain issue logs, and upload documentation to the eTMF
  • Present team metrics during internal meetings
  • Reconcile protocol deviations and assist with database lock activities
  • Complete other assigned responsibilities

Cerințe

  • A university or college degree is required
  • Relevant equivalent experience may be considered in place of formal education
  • Relevant work experience combined with education equivalent to a bachelor’s degree may substitute for a bachelor’s degree
  • Fluent written and spoken English
  • Approximately 3 years in a primary data management role supporting complex in-house studies, or at least 5 years of hands-on EDC, vendor, eCOA, IRT, and SAE data review and reconciliation
  • Six to eight years of data management experience, including at least one year managing sponsors directly
  • Experience supporting in-house study start-up, conduct, and closeout
  • Experience addressing customer concerns and managing Statements of Work and budgets is preferred
  • Knowledge of clinical trial processes, data management, clinical operations, Biometrics, and related system applications
  • Strong time management skills and the ability to meet productivity measures and project deadlines
  • Ability to contribute effectively in a team setting and collaborate with colleagues
  • Strong organizational, communication, interpersonal, teamwork, and collaboration skills
  • Knowledge of medical terminology
  • A university or college degree in life sciences, health sciences, information technology, or a related field is preferred
  • A scientific education or background is preferred
  • Detailed knowledge of Fortrea, its organizational structure, and standard operating procedures
  • At least 3 years of Electronic Data Capture experience
  • Previous Veeva EDC experience is advantageous
  • Willingness to work flexible shifts, overtime, and weekends when business needs require it

Beneficii

  • Medical insurance
  • Dental insurance
  • Vision insurance
  • Life insurance
  • Short-term disability coverage
  • Long-term disability coverage
  • 401(k) plan
  • Paid time off or flexible time off
  • Company bonus where applicable
  • Office-based and home-based work options
  • Flexible shifts based on business requirements

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