Clinical Program Operations Manager, Therapeutics & Innovation

Join Natera's Clinical Innovation & Therapeutics team as a Clinical Program Operations Manager. You will be responsible for the operational delivery of the team's oncology trials, including timelines, budgets, vendor performance, site management, and data flow, ensuring that studies are executed on schedule, within scope, and in a continuous state of inspection readiness. This position is accountable for translating approved protocols into activated sites, enrolled patients, and clean, lockable data.

Responsibilities

Operational delivery of oncology trials including timelines, budgets, vendor performance, site management, and data flow; Translating approved protocols into activated sites, enrolled patients, and clean, lockable data; Developing and maintaining integrated study timeline, critical path, and Gantt chart; Establishing dashboards, trackers, milestone reports, and risk/issue logs; Leading feasibility and site selection end to end; Managing site contracts, budgets, confidentiality agreements, essential documents, IRB/EC submissions, and green-light criteria; Monitoring site performance and implementing corrective action plans; Managing CRO and vendor selection, scopes of work, contracts, change orders, invoicing, and accruals; Governing vendor performance against KPIs and SLAs; Managing study budgets and resource plans; Maintaining trial master file completeness and inspection readiness; Ensuring compliance with ICH-GCP, regulations, and SOPs; Leading operational readiness for investigator meetings, site initiation visits, monitoring visits, steering committee meetings, and data review meetings; Managing data cleaning timelines, query resolution, and database lock readiness; Traveling up to approximately 25% to clinical sites and partner locations

Requirements

Bachelor's degree in a life science or related field; Minimum of 5 years of clinical research experience, including at least 3 years managing oncology trials in a program or project management capacity; Working knowledge of ICH-GCP, applicable FDA regulations, IRB/EC processes, and trial master file and inspection readiness requirements; Proficiency with CTMS, eTMF, EDC, and IRT systems, project management tools such as Smartsheet or MS Project, and Microsoft Office; Experience managing CRO and site contracts, budgets, and change orders; Ability to work independently, take ownership of outcomes, and maintain progress under competing priorities and compressed timelines; Ability to operate without an established playbook, adapting plans as the science, portfolio, and business continue to evolve; Willingness to engage at a detailed operational level and resolve obstacles proactively; Reliance on data, including enrollment curves, cycle times, query aging, and vendor performance metrics, to identify root causes of delay and test assumptions; Ability to guide cross-functional initiatives and build alignment across clinical, medical, and product organizations; Clear, direct written and verbal communication, including the ability to brief senior leadership concisely and hold vendors accountable to commitments; Builds and sustains effective working relationships internally and externally; Requires working with PHI (Protected Health Information) in paper and electronic formats, treating regulatory and quality requirements as foundational; Completes HIPAA/PHI privacy, compliance, and security training within 30 days of hire and maintains current status on Natera training requirements

Nice to have

Advanced degree (MS, PharmD, PhD); Demonstrated accountability for at least one oncology study from startup through database lock; Experience within small- to mid-sized biotechnology companies; PMP or equivalent project management certification

Benefits

Comprehensive medical, dental, vision, life and disability plans; Free testing for employees and immediate family members; Fertility care benefits; Pregnancy and baby bonding leave; 401k benefits; Commuter benefits; Employee referral program