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Clinical Research Site Lead

2 months ago

New York, New York, United States SciPro Inc. Full time

Job Summary

We are seeking a highly experienced Senior Manager to lead our Clinical Research Site Monitoring team at SciPro Inc. As a key member of our team, you will be responsible for overseeing the qualification and management of external stakeholders, including CROs and clinical sites.

Key Responsibilities

  • Provide strategic oversight of CRO operations, ensuring compliance with domestic and global regulatory guidelines.
  • Establish and maintain relationships with new external stakeholders, including CROs and clinical sites.
  • Oversee the qualification of new sites and ensure seamless site relationships to maximize patient and site experience.
  • Align company goals with new stakeholders, providing insight into pipeline progress and ensuring compliance with eQMS standards.
  • Have non-disciplinary responsibilities over CRAs and participate in onboarding new CRAs.

Requirements

  • Extensive experience in qualification and management of external stakeholders, with a strong background in CRO oversight.
  • Strong experience in CRA/CTM function within oncology-based biotech or CRO.
  • Minimum Bachelor's degree in a scientific or clinical field.
  • Ability to effectively utilize the CTMS and Trial Master File (TMF) to ensure SEME documents are promptly filed and site data is accurate.
  • Ability to travel domestically and internationally.