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Sponsor Oversight Manager/Senior

4 months ago

Redwood City, California, United States Adverum Biotechnologies Full time

Adverum is looking for a SOM/ Senior SOM (Sponsor Oversite Manager). The SOM/ Sr. SOM is a critical position within the clinical team at Adverum. In close collaboration with the Clinical Trial Manager and/or Study Director, the SOM/ Sr. SOM will work to manage and provide daily operational oversight of the Contract Research Organization (CRO), study vendors, and clinical trial sites. The SOM/ Sr. SOM will partner with the Medical Monitor and other internal and external constituents to ensure clinical trial activities and deliverables are completed on time and in accordance with regulatory requirements, Good Clinical Practice (GCP) guidelines, and company SOPs.

What you'll do:

  • Independently manages the study start-up activities for multi-center, US, and/or global-based studies
  • May perform on-site sponsor oversite visits (feasibility, SIV, IMV, Close-out) or with CRO CRAs as needed to assess the sites' and CRA's overall performance
  • Provides monitoring oversight by reviewing monitoring schedules, metrics, and reports
  • Responsible for clinical site training and site adherence to protocol, all applicable GCP/ICH guidelines, regulations, statutes and SOPs
  • Leads or participates in vendor management activities
  • Performs in-house routine data listing review
  • Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Supports CTM and/or Study Director and cross-functional representatives as required in relationship management tasks (e.g. contracts, study logistics, patient enrollments, safety, data management, etc.) to accurately coordinate clinical study activities
  • Mentors and coaches junior staff new to Clinical Research (e.g. Clinical Trial Assistant)
  • Assists with the development of protocol, informed consent development, CRFs, tracking forms, and other study-related documents
  • Performs other duties and assignments as required for the overall success of the projects. Duties my change based on the status of clinical programs and ongoing needs of the organization
  • Other responsibilities may be assigned as needed

About you:

  • Working knowledge of ICH/GCP and FDA guidelines
  • Effective verbal and written communication skills
  • Attention to detail and organizational skills
  • Ability to "roll up your sleeves" and individually contribute results to a research and development effort
  • Ophthalmology experience preferred but not required
  • Proficiency in MS Word, Excel, and PowerPoint
  • Ability to travel up to 20%
  • BS/BA, RN, or equivalent with at least 4 years of clinical trial monitoring/ clinical trial management and vendor management experience