The opportunity
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…
What you'll do
Develop and maintain the integrated study timeline, critical path, and Gantt: chart from study startup through database lock, and hold internal functions and vendors accountable to committed dates
Establish and maintain the dashboards, trackers, milestone reports, and risk: and issue logs that provide leadership and the steering committee with accurate, current program status
Identify risks early, drive mitigation plans to closure, and escalate issues: to leadership with a recommended course of action
Develop enrollment forecasts and manage cross-functional dependencies across: Regulatory, Quality, Data Management, Biostatistics, Laboratory Operations, and Medical Affairs
Lead feasibility and site selection end to end, including questionnaire: development, site scoring, selection recommendations, and activation planning
Manage site contracts and budgets, confidentiality agreements, essential: document collection, IRB/EC submissions, and green-light criteria through site initiation
What they're looking for
- Bachelor's degree in a life science or related field required; advanced degree (MS, PharmD, PhD) preferred
- Minimum of 5 years of clinical research experience, including at least 3: years managing oncology trials in a program or project management capacity
- Demonstrated accountability for at least one oncology study from startup through database lock preferred
- 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
- Experience within small: to mid-sized biotechnology companies preferred
- PMP or equivalent project management certification preferred