Trial Operations Manager (m/f/d)

Basel Stadt | Freie Mitarbeit 
Kategorie(n): Gesundheitswesen
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Referenznummer: 424746/1
Startdatum: asap
Projektdauer: 6 MM++
Ort: Basel Stadt

Meine Aufgaben:
  • Partner and agree with GPT/GCT/ICT/CTT on trials execution plans and timeline commitments in alignment with Trial Monitoring strategy and on behalf of the Trial Monitoring organization to achieve global and regional/local business
  • Communicate planned milestones to Trial Monitoring stakeholders and update GCT/ICT/CTTs on operational activities at the Region/CPO level, during the course of the trials to meet GPT Objectives
  • Participate in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
  • Provide ongoing information and regular updates to the Trial Monitoring organization, including remediation actions
  • Core member of the assigned TOM Development Unit Team
  • Actively participate in the development of reporting methodologies, and implement performance reporting for trial monitoring, ensure accurate and complete operational data within corporate systems (i.e ClinAdmin, DARWIN)
  • You may be the delegate of TOM Development Unit Head for specific teams or activities
  • Accountable for recruitment activities as per targets and reviews enrolment at the trial level, including responsibility for approval of changing recruitment commitment
  • Responsibility for forecasting, setting up contingency planning to ensure recruitment targets are achieved in accordance with trial execution plan
  • Communication of timelines for major milestone deliverables from start to end of enrollment, in coordination with CTT, regions and CPOs (with Clinical Study Managers)
  • Coordinate clinical data collection as per plan, including contingency planning and communication of timelines for major database lock milestone deliverables, in coordination with the Data Review Team, regions, and CPOs
  • Ensure timely site close-out activities, in coordination with CTT and CPOs (with Clinical Study Managers)
Meine Qualifikationen:
  • College or university degree with significant life science experience
  • Profound experience in clinical research, in planning/executing and/or monitoring clinical trials
  • Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
  • Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but ability to coordinate the activities of others
  • Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
  • Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
  • Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
  • Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities’ regulations, Novartis standards, and clinical development process
Meine Vorteile:
  • You will work in an international environment
Über Hays:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

Einsatzort: Basel Stadt


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