Senior Clinical Operations Specialist

1 semana atrás

São Paulo, São Paulo, Brasil beBeeManager Tempo inteiro US$90.000 - US$120.000
Key Responsibilities

The Study Start-Up Manager plays a pivotal role in the planning, execution and activation of assigned projects. This individual is accountable for ensuring compliance with company processes, GCP/ICH and regulatory requirements in a standalone country, operating country or satellite country. They lead all study start-up activities in close collaboration with the Feasibility Manager, Site Partnership Manager and global study team.

  • Supports country SSU strategy in collaboration with the Study Start-Up Team Lead, Country Head Portfolio and Cluster Head Portfolio.
  • Collaborates with the Country/Cluster Head Portfolio, Portfolio Team Leads and global study team to ensure timely completion of start-up activities and deliverables according to country commitments.
  • Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site milestone) in assigned projects.
  • Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable.
  • Coordinates the preparation and review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required.
  • Prepares and finalizes local submission packages for submission to IRB/IEC, CTA Hub (Europe: to new EU-CTR) and Health Authorities, as applicable.
  • Coordinates timely response to deficiency letters in close collaboration with local and global stakeholders.
  • Coordinates reportable events and notifications to IRB/IEC and Health Authorities, as applicable.
  • Accountable for timelines, accuracy and quality of country TMF documents in study start-up to ensure TMF inspection readiness.
  • Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC and SOP requirements.
Qualifications and Skills
  • Minimum 5 years' experience in clinical operations, overseeing project management and/or monitoring clinical trials.
  • Capable of leading in a matrix environment without direct reports.
  • Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution and monitoring.
Benefits and Opportunities

We offer a range of benefits and opportunities designed to support your well-being and work-life balance, including:

  • Annual leave entitlements
  • Health insurance offerings
  • Retirement planning options
  • Employee Assistance Programme
  • Life assurance
Our Culture and Values

At [Company], we are dedicated to providing an inclusive and accessible environment for all candidates and employees. We believe that diversity and inclusion are fundamental to our culture and values.

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