Senior Manager/Associate Director, Clinical Operations

Outpace Bio•Seattle, WA

1d•Remote

About The Position

The Senior Manager/Associate Director, Clinical Operations, with support and guidance from Clinical leadership, is responsible for all operational aspects of assigned cell-therapy clinical trial(s) from setup through final report. They ensure 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 (e.g., CRAs, CTAs, Logistics, etc.), as well as oversee CROs, vendors and consultants.

Requirements

Bachelorâ€™s Degree or ex-US equivalent required.
Minimum of 8 years of experience in the clinical research industry, including a minimum of 5 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 to actively develop strategies and drive smart decision making to support acceleration of trial timelines and enable a well-run trial.
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.
Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.

Responsibilities

Trial-level oversight and leadership of assigned cell-therapy clinical trial(s) in a cross-functional environment.
Obtains 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/required.
Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
Develops recruitment and slot management strategies.
Leadership 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 filing.
Risk identification, mitigation, and management, including timely issue review, escalation, and management to support trend analysis and risk prevention.
CTMS and eTMF management to ensure compliance/inspection readiness, support trend analyses and support timelines.
Review of EDC design specifications, participation in user acceptance testing, and contribution to development and review of associated plans and completion guidelines.
Review clinical data to ensure timely entry and readiness for data review meetings and support data cleaning/query process.
Review clinical monitoring reports to ensure timely completion and identification of issues.
Complete and maintain internal clinical trial metrics, dashboards and other internal updates.
Ensure trials are conducted in accordance with Outpace Bio and ICH/GCP standards.
Coordinates & manages various tasks in collaboration with other roles to achieve site readiness, such as trial materials and approval for drug shipping/receipt according to procedure.
Other responsibilities as assigned.