[Remote] Senior Manager/Associate Director, Clinical Operations

Note: The job is a remote job and is open to candidates in USA. Outpace Bio is pioneering the future of cell therapy for solid tumors through AI-powered protein design. The Senior Manager/Associate Director, Clinical Operations is responsible for overseeing all operational aspects of assigned cell-therapy clinical trials, ensuring compliance and efficiency throughout the trial process.ResponsibilitiesTrial-level oversight and leadership of assigned cell-therapy clinical trial(s) in a cross-functional environmentObtains and maintains in-depth understanding of the trial protocol and related procedures in order to contribute strongly to trial team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/requiredDevelops strong vendor and site relationships and ensures continuity of relationships through all phases of the trialDevelops recruitment and slot management strategiesLeadership of assigned meetings (cross-functional [internal], vendor, and/or investigator) and provision of regular updates on trial status, e.g., agenda development, minutes curation and filingRisk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk preventionCTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelinesReview of EDC design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and completion guidelinesReview clinical data to ensure timely entry and readiness for data review meetings and support data cleaning/query processReview clinical monitoring reports to ensure timely completion and identification of issuesComplete and maintain internal clinical trial metrics, dashboards and other internal updatesEnsure trials are conducted in accordance with Outpace Bio and ICH/GCP standardsCoordinates & manages various tasks in collaboration with other roles to achieve site readiness, such as trial materials and approval for drug shipping/receipt according to procedureOther responsibilities as assignedSkillsBachelor's Degree or ex-US equivalent requiredMinimum of 8 years of experience in the clinical research industry, including a minimum of 5 years of trial management experienceRobust 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 to actively develop strategies and drive smart decision making to support acceleration of trial timelines and enable a well-run trialExcellent organizational and time management skills, strong attention to detailAbility to work independently and thrive in a fast-paced evolving environmentGood understanding of FDA and ICH GCP guidelinesExcellent verbal and written communication skillsBenefitsFull time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, health savings account, commuter benefits, legal benefits, and 401k plan which includes an employer match.Employees may receive stock option grants to be outlined in their offer of employmentA performance bonusFlexible PTOPaid sick leave which complies with local requirementsFifteen paid holidays plus a winter shutdownA generous paid parental leave policy to all regular full-time employeesCompany OverviewOutpace Bio develops innovative cell therapies to enhance cancer treatment efficacy. It was founded in 2020, and is headquartered in Seattle, Washington, USA, with a workforce of 51-200 employees. Its website is https://www.outpacebio.com.