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Senior Manager Site Monitoring Lead

2 months ago

Reston, Virginia, United States SciPro Full time

Senior Manager, Clinical Research Site Monitoring (Oncology)

About the Role

SciPro is seeking a seasoned Senior Manager to lead Clinical Research Site Monitoring efforts in the Oncology space. 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 domestic and global Clinical Trials, with a focus on Oncology
  • Establish and maintain relationships with new external stakeholders, including CROs and Clinical Sites
  • Ensure compliance with eQMS standards and domestic and global Regulatory guidelines
  • Lead 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 in Scientific and/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 & internationally

About SciPro

SciPro is a leading provider of Clinical Research Site Monitoring services. We are committed to delivering high-quality solutions that meet the evolving needs of our clients.