Senior Project Manager - Oncology

August 27

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Catalyst Clinical Research

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Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500

Description

• Responsible for the routine cross-functional operations of assigned studies for one or more clients • Act as the team leader, ensuring that assigned studies are delivered successfully, on-time, within budget • Develop, implement and communicate project plans, monitoring plans, regulatory plans, and all other applicable study materials • Facilitate team training in accordance with the protocol and/or project requirements • Direct all project staff across functional areas to facilitate study progress • Oversee activities with respect to regulatory document collection and Trial Master File maintenance • Work closely with Central Site Services and Clinical Operations team on initial investigator recruitment and evaluation • Oversee negotiation, or may negotiate, of the site contracts and/or budgets • Work with sponsor to determine and implement patient retention strategies as needed • Develop and maintain a close working relationship with sponsor study management team

Requirements

• University/college degree (life sciences preferred) or certification in a related allied health profession from an appropriately accredited institution • 7 years previous experience in a Project Manager role in a clinical research setting • Experienced managing oncology projects - working in either cell therapy or CAR-T • Strong knowledge of the drug development process and FDA regulations • Excellent written, oral communication and presentation skills • Excellent interpersonal and organizational skills with demonstrated attention to detail • Ability to read, write and speak fluent English • Ability to build positive, productive client and team member relationships • Demonstrated problem-solving capabilities, critical thinking, and analytical skills • Good computer skills with good working knowledge of a range of computer applications • Ability to meet deadlines, multitask, and prioritize based on project needs • Ability to make sound decisions based on available information • Ability to work both in a team and independently • Ability to lead team meetings and teleconferences and provide accurate and comprehensive minutes • Ability and willingness to travel to investigator meetings, investigative sites and bid defense meetings, etc., up to 25%