Adverum is looking for a SOM (Contract - Sponsor Oversite Manager). The SOM (contract) is a critical position within the clinical team at Adverum. In close collaboration with the Clinical Trial Manager and/or Study Director, the SOM will work to manage and provide daily operational oversight of the Contract Research Organization (CRO), study vendors, and clinical trial sites. The 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
$60 - $70 an hourThis is a contract role, starting out at 6 months. Hourly rate will depend on experience.
About Us
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum, Inclusion and Diversity are at our core.
We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientationApply for this job
