Clinical Program Operations Manager, Therapeutics & Innovation

Position Summary 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. You will work in close partnership with the team's field-based Medical Science Liaison, who leads scientific exchange and investigator engagement, the Head of Clinical Development and Medical Affairs, while you drive vendor oversight, and cross-functional accountability. Primary Responsibilities Program Execution and Timeline Management 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 datesEstablish and maintain the dashboards, trackers, milestone reports, and risk and issue logs that provide leadership and the steering committee with accurate, current program statusIdentify risks early, drive mitigation plans to closure, and escalate issues to leadership with a recommended course of actionDevelop enrollment forecasts and manage cross-functional dependencies across Regulatory, Quality, Data Management, Biostatistics, Laboratory Operations, and Medical Affairs Study Startup and Site Operations Lead feasibility and site selection end to end, including questionnaire development, site scoring, selection recommendations, and activation planningManage site contracts and budgets, confidentiality agreements, essential document collection, IRB/EC submissions, and green-light criteria through site initiationMonitor and manage site performance against operational metrics, including enrollment versus target, screen failure rates, protocol deviations, query aging, and site payments, and implement corrective action plans for underperforming sitesRefer scientific, protocol interpretation, and referral network matters to the Medical Science Liaison and Head of Clinical Development Vendor and CRO Management Manage CRO and vendor selection, scopes of work, contracts, change orders, invoicing, and accrualsGovern vendor performance against defined KPIs and service level agreements, lead governance meetings, and initiate corrective action when deliverables are at riskCoordinate central laboratory, IRT, EDC, eCOA, imaging vendors, and clinical supply and logistics Budget and Resource Oversight Manage study budgets and resource plans, track forecast versus actual spend, and maintain accrualsIdentify variances early and present leadership with options and the associated cost and schedule trade-offs Quality, Compliance, and Documentation Maintain trial master file completeness and inspection readiness on an ongoing basisPartner with Quality Assurance on deviations, CAPAs, audits, and inspection preparationEnsure study conduct is compliant with ICH-GCP, applicable regulations, and internal SOPs, and coordinate the operational elements of safety reporting with PharmacovigilanceDevelop and maintain standardized project management templates, working practices, and operating cadences that support consistent execution across studies Meeting and Data Review Operations Lead operational readiness and logistics for investigator meetings, site initiation visits, monitoring visits, steering committee meetings, and data review meetings, including agendas, materials preparation, and tracking of action items to closureManage data cleaning timelines, query resolution, and database lock readiness so that scientific review proceeds on scheduleTranslate protocol and clinical objectives into executable operational plans, monitoring strategies, and resourcing models Field Presence Travel up to approximately 25% to clinical sites, CROs, investigator meetings, and key partner locations to oversee execution, resolve operational issues, and represent Clinical Operations Qualifications Bachelor's degree in a life science or related field required; advanced degree (MS, PharmD, PhD) preferredMinimum of 5 years of clinical research experience, including at least 3 years managing oncology trials in a program or project management capacityDemonstrated accountability for at least one oncology study from startup through database lock preferredWorking knowledge of ICH-GCP, applicable FDA regulations, IRB/EC processes, and trial master file and inspection readiness requirementsProficiency with CTMS, eTMF, EDC, and IRT systems, project management tools such as Smartsheet or MS Project, and Microsoft OfficeExperience managing CRO and site contracts, budgets, and change ordersExperience within small- to mid-sized biotechnology companies preferredPMP or equivalent project management certification preferred Knowledge, Skills, And Abilities Ability to work independently, take ownership of outcomes, and maintain progress under competing priorities and compressed timelinesAbility to operate without an established playbook, adapting plans as the science, portfolio, and business continue to evolveWillingness to engage at a detailed operational level and resolve obstacles proactivelyReliance on data, including enrollment curves, cycle times, query aging, and vendor performance metrics, to identify root causes of delay and test assumptionsAbility to guide cross-functional initiatives and build alignment across clinical, medical, and product organizationsClear, direct written and verbal communication, including the ability to brief senior leadership concisely and hold vendors accountable to commitmentsBuilds and sustains effective working relationships internally and externallyRequires working with PHI (Protected Health Information) in paper and electronic formats, treating regulatory and quality requirements as foundationalCompletes HIPAA/PHI privacy, compliance, and security training within 30 days of hire and maintains current status on Natera training requirements The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $116,200—$145,200 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. What We Offer Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit www.natera.com. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: https://www.natera.com/notice-of-data-collection-california-residents/ Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. 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