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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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Locurile de muncă ale companiei

Senior Clinical Data Manager - Sponsor Dedicated, Fortrea (Poland Remote)

Lead sponsor-dedicated clinical data management for Fortrea, overseeing studies, vendors, budgets, data quality, standards, and client relationships.

BGBulgariaEEEstoniaGRGreciaHUUngariaPLPoloniaRORomâniaSKSlovaciaRemoteNormă întreagăSeniorLimbă Obligatorie: englezăCercetare clinică

Descriere

  • Lead Clinical Data Management activities for assigned projects or indications
  • Hold global accountability and act as the second project-level contact
  • Direct studies involving healthy volunteers or patients, multiple sites, complex protocols, demanding client-management needs, or accelerated timelines
  • Coordinate and prioritize workloads and deliverables
  • Plan and produce Clinical Data Management deliverables at program and project levels
  • Oversee vendor contracts, staffing, budgets, and vendor performance
  • Communicate and negotiate with program-level stakeholders
  • Act as the principal Clinical Data Management contact
  • Implement consistent Clinical Data Management processes and documentation across assigned programs
  • Supervise external providers and internal teams to deliver high-quality data in line with procedures and standards
  • Advise on company standards, processes, systems, and expectations
  • Manage risks and resolve or escalate Clinical Data Management improvement and technology issues
  • Build knowledge of CDASH, SDTM, and other recognized industry standards and their effects on programming teams
  • Review therapeutic-area-specific data capture and standards through lessons learned, then share findings
  • Coach Clinical Data Management colleagues and stakeholders
  • Direct project-level activities that support study delivery

Cerințe

  • A university or college degree in life sciences, pharmacy, or a related field is preferred, or certification in a related allied health profession from an appropriately accredited institution
  • 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 mentoring
  • Demonstrated ability to manage customer negotiations
  • Experience managing Statements of Work and budgets
  • Extensive clinical data management experience
  • Experience leading studies in a CRO or pharmaceutical environment
  • Strong oral, written, and presentation communication skills
  • Thorough knowledge of clinical trial processes and data management, clinical operations, biometrics, quality management, and systems applications
  • Working knowledge of CRO-industry relationships and regulatory obligations with pharmaceutical and biotechnology companies
  • Ability to lead by example in project strategy and in achieving departmental goals, objectives, and initiatives
  • Demonstrated management and interpersonal capabilities

Beneficii

  • Highly competitive compensation packages
  • Pension contributions
  • Complimentary health insurance plans
  • Allowances for remote work
  • Support for work-life balance
  • Flexible working hours
  • Comprehensive onboarding with guidance from a personal mentor
  • Permanent employment contract with Fortrea Drug Development
  • Career advancement opportunities
  • Mentoring, training, and individualized development planning

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