Catalyst Clinical Research
Listen, Devise, Breakthrough
Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider
201 - 500
Senior Project Manager-Oncology, Europe
July 5, 2023
Catalyst Clinical Research
Listen, Devise, Breakthrough
Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider
201 - 500
Description
• Responsible for routine cross-functional operations of assigned studies • Team leader ensuring successful delivery of assigned studies • Deliver studies on-time, within budget, with highest level of quality • Develop, implement and communicate project plans • Facilitate team training • Oversee regulatory document collection and Trial Master File maintenance • Assist with initial investigator recruitment and evaluation • Oversee site contracts, budgets, and distribution of study materials • Work with sponsor to implement patient retention strategies • Resolve site and facility issues • Review and sign off monitoring reports • Manage project documentation • Establish strong relationships with sponsor and investigative sites • Lead project team meetings • Coordinate and execute Investigator Meetings • Create and distribute study-specific newsletters • Escalate issues and critical project matters in a timely manner
Requirements
• University/college degree (life sciences preferred) or related allied health profession • 7 years previous experience in Project Manager role in clinical research setting • Experienced managing oncology projects • Strong knowledge of drug development process, FDA regulations, and ICH GCP guidelines • Excellent written, oral communication and presentation skills • Excellent interpersonal and organizational skills • Fluent in English • Ability to build positive, productive client and team member relationships • Problem-solving capabilities, critical thinking, and analytical skills • Good computer skills • Ability to meet deadlines, multitask, and prioritize • Ability to make sound decisions based on available information • Ability to work both in a team and independently • Ability to lead team meetings and provide accurate minutes • Willingness to travel up to 25% to meetings and investigative sites
Benefits
• Highly customizable clinical research solutions • Multi-therapeutic global resourcing and functional services • Full-service oncology CRO offering • Customer-centric solutions • Breakthrough clinical development studies • Expert teams and innovative technologies
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