Senior Project Manager- Oncology

February 21

Catalyst Clinical Research

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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 for one or more clients • Ensure assigned studies are delivered successfully, on-time, within budget, and with high quality • Coordinate and manage clinical trials from start-up through close-out activities • Develop and communicate project plans, monitoring plans, and regulatory plans • Facilitate team training and oversee activities across functional areas • Develop study-specific SOPs and management tools • Oversee regulatory document collection and Trial Master File maintenance • Work closely with Central Site Services and Clinical Operations team • Establish strong working relationships with sites, sponsor study management team, and investigative sites • Serve as liaison with sponsor and project team, coordinate Investigator Meetings, and lead internal project team meetings

Requirements

• University/college degree or certification in life sciences or related allied health profession • 7 years experience in a Project Manager role in clinical research with a progression of increased responsibility • Experience managing oncology projects in cell therapy or CAR-T • Strong knowledge of drug development process, FDA regulations, and ICH GCP guidelines • Excellent communication, interpersonal, and organizational skills • Fluent in English • Ability to build positive client and team relationships, problem-solve, think critically, and prioritize • Good computer skills with knowledge of a range of applications • Ability to meet deadlines, multitask, make sound decisions, work independently and in a team, and lead meetings • Willingness to travel up to 25%

Benefits

• Competitive salary • Health and dental insurance • Retirement plan options • Paid time off and holidays