Clinical Project Director

2 semanas atrás

Buenos Aires Espírito Santo Brazil beBeeClinicalOperations Tempo inteiro US$55.000 - US$95.000

Job Title:

Clinical Operations Leader

Job Description:

The Clinical Trial Manager II oversees the operational management and oversight of clinical investigative sites, ensuring timely quality deliverables in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.

This role is ideal for those who enjoy working in a mid-sized contract research organization environment, have previous experience in managing clinical monitoring activities, and are interested in dermatology and rheumatology therapeutic areas.

Responsibilities:

  • Ensures timely quality deliverables for clinical monitoring activities.
  • Identifies quality issues and trends related to site performance and clinical monitoring activities.
  • Serves as a point of contact for CRAs and Lead CRAs for assigned projects.
  • Provides mentoring/oversight of CRAs and Lead CRAs.
  • Performs site visit report review and tracks metrics to ensure compliance.

Requirements:

At least 8 years of clinical research experience, including prior monitoring experience and at least 2 years of experience acting in a Lead CRA or Clinical Team Leader role.

Knowledge and Skills:

Ideally suited for professionals with a strong background in ICH/GCP standards and regulatory requirements, excellent Microsoft Office skills, and the ability to work in a fast-paced evolving environment, establishing effective relationships with colleagues, sites, and sponsors.

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