Adverum Biotechnologies

Clinical Research

• Support all phases of clinical research including planning, implementation, completion, and final reports of clinical trials.
• Serve as primary study team contact to manage study start-up, conduct, and close-out.
• Lead cross-functional study execution team to meet project milestones, budgets, and compliance with ICH/GCP and local regulatory authorities.
• Develop, plan, and forecast budget requirements for clinical programs and study sites.
• Manage CRO and vendor evaluation, selection, training, and oversight.
• Facilitate site feasibility and selection processes; conduct sponsor quality monitoring/oversight visits as needed.
• Provide strategic and operational input into study documents (protocol, ICF, CRFs, pharmacy and laboratory manuals).
• Oversight of preparation and submission of safety reports (pharmacovigilance).
• Forecast and manage investigational drug labeling, packaging and distribution; supply chain management.
• Ensure clinical record keeping in preparation for audits and inspections.
• Identify and engage thought leaders, investigators, cooperative groups, and other experts for study design and interpretation.
• In conjunction with data management, assist with eDC development, data listings, issue and query resolution.
• Collaborate on development and set-up of study systems (IVRS/IWRS, site payments and CTMS).
• Develop and report key executional metrics for oversight of clinical trials.
• Assist with creating, reviewing and implementing SOPs and processes in clinical development.
• Ensure documentation is prepared for inclusion in regulatory product submissions.

Senior Clinical Trial Manager