Clinical Research Director

Há 6 dias


São Paulo, São Paulo, Brasil Fortrea Tempo inteiro
Job Summary

We are seeking a highly skilled Clinical Research Manager to join our team at Fortrea, a leading global contract research organization. As a Clinical Research Manager, you will be responsible for managing clinical trials from feasibility to close-out, ensuring compliance with regulatory requirements and company standards.

Key Responsibilities
  • Manage clinical trials from feasibility to close-out, ensuring compliance with regulatory requirements and company standards.
  • Develop and implement project plans, timelines, and budgets for clinical trials.
  • Collaborate with cross-functional teams, including clinical operations, data management, and biostatistics, to ensure successful trial execution.
  • Identify and mitigate risks associated with clinical trials, ensuring compliance with company policies and regulatory requirements.
  • Develop and maintain relationships with investigators, site staff, and other external partners to ensure successful trial execution.
  • Ensure compliance with Good Clinical Practice (GCP) and regulatory requirements, including ICH E6 (R2) and 21 CFR Part 11.
  • Develop and implement quality control processes to ensure data integrity and accuracy.
  • Collaborate with the clinical operations team to develop and implement clinical trial protocols, informed consent forms, and other study-related documents.
  • Ensure compliance with company policies and procedures, including those related to data management, biostatistics, and regulatory affairs.
Requirements
  • Bachelor's degree in a life science or related field.
  • Minimum 5 years of experience in clinical research, including experience in managing clinical trials.
  • Strong knowledge of clinical trial regulations, including ICH E6 (R2) and 21 CFR Part 11.
  • Excellent communication and project management skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks and projects.
  • Strong analytical and problem-solving skills.
  • Ability to travel up to 20% of the time.
What We Offer

Fortrea offers a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We also offer opportunities for professional growth and development, including training and education programs.



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