Chief Clinical Operations Specialist

Há 3 dias

Rio de Janeiro, Rio de Janeiro, Brasil beBeeClinical Tempo inteiro R$1.800.000 - R$2.100.000
Clinical Team Manager Job Opportunity

We are seeking a highly skilled Clinical Team Manager to join our team.

About the Role

The successful candidate will be responsible for managing all clinical operational and quality aspects of allocated studies in compliance with ICH GCP. This includes assuming lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities, or taking on additional responsibilities such as process improvements, managing complex programs, or wider management roles.

Key Responsibilities:
  • Develop and implement clinical tools, such as Monitoring Plans and Guidelines, in conjunction with Data Quality Plans.
  • Contribute to the development of Master Action Plans (MAPs) for providing clinical-related documents.
  • Ensure timely setup, organization, content, and quality of Trial Master Files (TMFs).
  • Participate in the design and development of Case Report Forms (CRFs), CRF guidelines, patient informed consent templates, and other protocol-specific documents.
  • Collaborate with project managers to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
  • Regularly communicate with teams and lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
  • Implement and train standardized clinical monitoring processes within studies and according to corporate policies.
  • Responsible for the timely archiving of documents and study materials.
  • Monitor clinical trials to assess performance and ensure contractual obligations are met. May conduct Accompanied Field Visits (AFVs) and be accountable for project financials.

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