Thermo Fisher Scientific
Thermo Fisher Scientific
Thermo Fisher Scientific dezvoltă și furnizează tehnologii, produse de laborator și servicii farmaceutice care sprijină cercetarea științifică și asistența medicală. Activitatea sa acoperă cercetarea în domeniul științelor vieții, rezolvarea problemelor analitice, creșterea productivității laboratoarelor, diagnosticarea, precum și dezvoltarea și producția de terapii. Compania își deservește clienții printr-o echipă globală și un portofoliu de mărci care include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon și PPD. Oportunitățile de carieră includ activitățile științifice, medicale, de producție, logistice și de servicii care susțin aceste oferte.

Local Clinical Trial Manager - Philippines (Hybrid)

Lead local oncology clinical trials for Thermo Fisher Scientific in the Philippines, overseeing compliant study delivery, site performance, timelines, quality, and budgets.

Descriere

  • Oversee clinical operations and quality for assigned low- to moderate-complexity studies in accordance with ICH GCP
  • Create clinical tools, monitoring plans, data quality plans, and contributions to master action plans
  • Establish, maintain, organize, and archive local and central Trial Master File records
  • Support the development of CRFs, CRF guidelines, informed consent templates, and study-specific documents
  • Partner with project managers and clinical teams on client meetings, bid defenses, handoffs, deliverables, timelines, resources, and quality objectives
  • Roll out standardized clinical monitoring processes and train teams in their use
  • Track clinical timelines and metrics, report progress, execute recovery measures, review monitoring visit reports, and oversee CRF collection and query resolution
  • Monitor or co-monitor trials on an ongoing basis and evaluate performance against contractual commitments
  • Perform Accompanied Field Visits and oversee project finances in smaller regions when needed
  • Liaise with study sites about protocols, patient participation, case report forms, and study-related issues
  • Coordinate study start-up, ethics committee submissions, and regulatory submissions as appropriate
  • Review ethics committee questions and ensure timely follow-up
  • Contribute to clinical activity forecasts and oversee clinical resources, assignments, delegations, and additional staffing needs
  • Travel to domestic and international study sites as required

Cerințe

  • Bachelor’s degree or an equivalent relevant academic or vocational qualification
  • At least five years of comparable professional experience
  • Demonstrated oncology experience
  • Strengths in leadership, mentoring, training, planning, organization, interpersonal communication, problem-solving, judgment, and decision-making
  • Working knowledge of clinical monitoring practices, processes, and requirements
  • Professional fluency in English
  • Knowledge of budgeting, forecasting, fiscal oversight, and project finances
  • Understanding of applicable regulations, including ICH/GCP and FDA guidelines
  • Proficiency with Outlook, Excel, Word, and comparable workplace applications
  • Ability to perform effectively in a changing environment and multicultural matrix organization
  • Ability to assess workloads against project budgets and reallocate resources when needed
  • Willingness and ability to travel domestically and internationally and drive to study sites

Beneficii

  • Work within a global team
  • Opportunities to collaborate and develop professionally
  • Exposure to scientific innovation and excellence

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