Project Manager

Responsibilities

• Plan, track, and deliver high-quality trial execution for assigned clinical trials from protocol inception through study close out
• Manage Scope of Work (SOW) consistent with targeted timelines and budgets
• Lead cross-functional teams and manage sponsor expectations and communications
• Proactively identify, mitigate, and escalate project risks and issues
• Oversee study vendors, patient enrollment, and liaison with investigators and sites
• Ensure compliance with ICH GCP requirements and company SOPs
• Develop and implement project plans including Clinical Monitoring, Communication, and Vendor Oversight plans
• Monitor and QC the electronic Trial Master File (eTMF)
• Collaborate with Data Management and Clinical Science on protocol deconstruction and eCRF development
• Facilitate Corrective and Preventative Action (CAPA) processes as needed

Requirements

• Minimum of a BS/BA in a biomedical discipline or equivalent education
• Minimum of 5 years of experience in clinical research methodology and product development (IND, study design, monitoring, data management, etc.)
• Prior project management or project lead coordination experience
• Proficiency in Microsoft Office Suite
• Ability and willingness to travel as needed

Preferred Qualifications

• Experience in the bid defense process

About the Company

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology and Catalyst Flex, offering full-service oncology CRO and multi-therapeutic global functional services.