Outpace Bio

Senior Manager/Associate Director, Clinical Operations

Seattle, WA · Director · Full-time

No sponsorship$160k-$217kDetected 74 days ago

GCPLogisticsClinical TrialsClinical ResearchFDA RegulatoryCRISPRResearchLeadershipCommunicationCollaborationCritical ThinkingTime Management

About the role

Our Momentum In August 2024, Outpace Bio secured an oversubscribed $144 million Series B financing, led by RA Capital Management and supported by a premier syndicate of life science investors.

Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
Develops recruitment and slot management strategies.
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.
Complete and maintain internal clinical trial metrics, dashboards and other internal updates.
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.

Bachelor'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).
Ability to work independently and thrive in a fast-paced evolving environment.

Working at Outpace offers an exciting opportunity to contribute to groundbreaking research that has the potential to transform the lives of people around the world.
Outpace Bio is committed to a diverse workforce.
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.
Outpace Bio does not accept unsolicited resumes from any source other than candidates.
The submission of unsolicited resumes by recruitment or staffing agencies to Outpace Bio or its employees is strictly prohibited unless contacted directly by Outpace Bio's internal team.
Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Outpace Bio and will not owe any referral or other fees.

OPB-101 is advancing toward IND clearance and first dosing in 2025 for patients with advanced platinum-resistant ovarian cancers.
They ensure assigned trials are executed with quality, compliance and efficiency, in accordance with regulations, timelines and budget.

The salary range is based on Outpace Bio's reasonable estimate of base salary for this role at the time of posting.

This listing is sourced directly from Outpace Bio's careers page and normalized into a canonical job model.