Part time 20/hrs week.
The Senior Clinical Project Manager is responsible for the design, execution, and results of clinical studies including complex, multi-center pivotal trials. This includes developing strategic approach, building the project plan, developing the protocol, initiating and executing the clinical study, and working with Regulatory to use study results for product approvals. Studies must be conducted meeting enrollment timelines and budgets. The position ensures all studies are conducted in compliance with GCP and all applicable standards and regulations.
· Provide operational leadership and accountability to meet corporate clinical goals, including execution of clinical studies in accordance with the protocol; meeting study timelines and budgets
· Ensure the design and conduct of the clinical studies is done in full compliance with GCP and regulatory standards
· Identify potential vendors for the clinical trial execution, including CROs, Monitors, EDC data management systems, Imaging Core Labs, and Biostatisticians. Qualify and select vendors
· Direct site selection and qualification processes
· Negotiate site, investigator, and vendor contracts and budgets in collaboration with Finance & Legal Departments
· Prepare all documentation associated with clinical studies to include case report forms, informed consent documents, investigator agreements, investigator brochures, case report form completion guidelines, logic checks and data handling guidelines and other required documents
· Plan, monitor and report patient enrollment and implement corrective actions as necessary to meet enrollment targets
· Bachelor’s degree in the life sciences or health care field/Master’s degree desired
· 6 - 8 years in direct clinical project management experience within the biopharmaceutical or medical device industry
· Demonstrated experience as a Project Manager on multi-center, FDA regulated IDE and/or IND studies
· Travel required of 25%-75% domestic and international may be required.