Cindy Shambaugh
Clinical Research | Clinical Operations | Trial Management | Project Management
- Role
- Director, Clinical Trial Management at Intra-Cellular Therapies
- Location
- Marietta, GA, US
- LinkedIn followers
- 500 followers
About Cindy Shambaugh
Mission driven and skilled at leading the execution of global clinical programs and high functioning teams, ensuring quality trials. Focused on operational excellence, encompassing strategy, operational execution, and regulatory compliance. Leveraging a strong foundation in clinical operations and project management, fostering collaboration across teams and committed to advancing clinical research that addresses complex healthcare challenges.
Experience
Director, Clinical Trial Management
Jun 2023 — Present
Accountable for execution of clinical programs, ensuring that high-quality clinical trials are conducted within the approved budget and timelines. Provides input to Clinical Development Plans, including forecasts for costs and timelines of proposed clinical trials. Provides operational input to protocol synopses and protocols. In conjunction with Clinical Development, determines vendor strategy. Oversees vendor management activities including selection and oversight of CRO. Authors or approves Vendor Oversight Plan and ensures compliance. Acts as a point of escalation for vendor issues. Oversees the development of operational study plans, ensuring conformance to regulatory and GCP requirements, ITI standards, and vendor agreements. In conjunction with Clinical Development, determines the country / site strategy, considering quality, timelines, and budget. Evaluates operational data to identify risks to program success; implements mitigation strategies and preventive / corrective actions across program. Leads and/or contributes to department initiatives (e.g, SOP development, system deployment). Provides line management (hiring, training, coaching, performance reviews) to Clinical Trial Managers and Clinical Trial Associates.
Education
Purdue University
Bachelor of Arts - BA
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