Clinical Oversight Lead

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Summary of Position:

Job Title:  Clinical Oversight Lead

Reports to:  Senior Director, Clinical Operations

Employment Type:  Contractor Part-Time (6 – 12 month assignment)

Summary:

This a a 6 – 12 month contract assignment.  The Clinical Oversight Lead (COL) is responsible for the assessment of clinical trial site performance and adequacy of monitoring activities to ensure compliance with the trial protocol, ICH-GCP guidelines, applicable SOPs, any other trial specific plans, clinical trial site and CRO site management and monitoring contractual obligations, and country specific regulations. Proactively identifies and communicates site management and monitoring risks to Trial Management.

Key roles and responsibilities of the Clinical Oversight Lead

  • Perform independent, impartial assessment and review of clinical trial site performance and monitoring activities
  • Indirect and direct assessment of the adequacy of monitoring and site performance against study-specific key risk / performance indicators and compliance to the protocol, operational plans, processes, and trial SOPs in accordance with ICH GCP E6R2
  • Detailed remote review of the clinical database and associated systems
  • Regular and timely reporting of findings, potential root cause(s) and mitigation strategy to trial management team
  • Proactively identify and control potential issues at and across sites that could impact
    • Patient safety
    • Quality of data
    • Study objectives
  • Assist in the proactive identification of gaps in processes /plans and assessment for process improvements and efficiencies.
  • Support other objectives for the clinical operations department, as needed

Required Skills & Abilities: 

  • Proficient with on-site monitoring activities (including qualification, initiation, routine monitoring and closeout visits)
  • Thorough knowledge of drug development and clinical trial processes, scientific research concepts, data management and clinical operations
  • Oncology experience is strongly preferred
  • CRA Management (preferred for FSP Model)
  • Experience with Risk Based Monitoring (preferred)
  • Experience with EDC systems
  • Demonstrated knowledge and understanding of FDA/EMA/GCP/ICH guidelines including E6R2
  • Excellent oral and written skills

Qualifications:

  • BS/BA degree or equivalent (background in life sciences preferred)
  • 7-10+ years of field monitoring and management within the pharmaceutical industry

Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.

Company Overview: Aravive, Inc. is a a late clinical-stage oncology company developing transformative, targeted therapeutics to treat metastatic disease. The company is based in Houston, Texas, and has a satellite office in the Research Triangle Park area in NC.  For more information, please visit our website at https://aravive.com.

Please send resumes and cover letters to info@aravive.com