Senior Clinical Trial Manager

4 days ago

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Logo of Outpace Bio

Outpace Bio

Cell Therapy • Protein Design • Cell Engineering • Cytokines • Immuno-oncology

Description

•The Senior Clinical Trial Manager (Sr CTM) is responsible for all operational aspects of assigned cell-therapy clinical trial(s) from setup through final report. •The Sr CTM ensures assigned trials are executed with quality, compliance and efficiency, in accordance with regulations, timelines and budget. •The candidate will coordinate the activities of several other clinical team members, as well as oversee CROs, vendors and consultants.

Requirements

•Bachelor’s Degree or ex-US equivalent required. •Minimum of 6 years of experience in the clinical research industry, including a minimum of 3 years of trial management experience. •Robust oncology experience required including early-stage experience and cell or gene therapy (highly complex such as CAR-T). •Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives. •Excellent organizational and time management skills, strong attention to detail. •Ability to work independently and thrive in a fast-paced evolving environment. •Good understanding of FDA and ICH GCP guidelines. •Excellent verbal and written communication skills.

Benefits

•Full time employees and their eligible dependents may enroll in medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. •Employees may receive stock option grants outlined in their offer of employment. •Flexible PTO, paid sick leave, and fifteen paid holidays plus a winter shutdown. •Generous paid parental leave policy for all regular full-time employees.

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