Cortney Galasso
Senior Clinical Trial Manager @Avidity Biosciences, Inc.
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WORK HISTORY
Senior Clinical Trial Manager @Avidity Biosciences, Inc.
Act as the clinical operations representative in a variety of cross-functional teams.• Collaborate with the program Clinical Operations Lead to develop and manage study level timelines and budgets.• Manages clinical study vendors.• Establish key deliverables and KPIs in management of CRO and vendors.• Collaborate with CRO to identify and develop training needs for site staff, CRAs, and vendors specific to the study protocol and processes, including presenting these at Investigator Meetings and Kick-off meetings.• Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees.• Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables.• Responsible for management and/or oversight of eTMF structure, plans and quality.• Manage study activities including, investigator selection, drug supply projections, study start-up, subject recruitment & retention, data collection, and database locks, study drug accountability and study closeout.• Actively contribute to technical and study design discussions, providing input toward clinical trial outlines, protocols, informed consent forms, and clinical study reports.• Collaborate with functional team members to draft/revise, finalize, and implement project plans, study-specific training, system builds, CRF designs, UATs.• Identify issues and risks with cross functional teams and service providers; develop and present proposed solutions and provide oversight of timely resolution in a collaborative approach.• Collaborate with data management (internal or CRO vendor) and CRAs to ensure data quality and compliance with data cleaning timelines• Lead and/or contribute to department process improvements/initiatives and SOPs.• Provide direction and mentoring to junior team members.• Escalate pertinent CRA performance and site compliance issues when necessary.• Ensure GxP and SOP training tasks are completed in a timely manner.
EDUCATION
Colorado State University
B.S.
ABOUT CORTNEY GALASSO
Senior Clinical Trial Manager at Avidity Biosciences
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