<h2>POSITION SUMMARY</h2> 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. <h2>PRIMARY RESPONSIBILITIES</h2> <h3>Program Execution and Timeline Management</h3> <ul> <li style="color: #000000 !important;">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</li> <li style="color: #000000 !important;">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</li> <li style="color: #000000 !important;">Identify risks early, drive mitigation plans to closure, and escalate issues to leadership with a recommended course of action</li> <li style="color: #000000 !important;">Develop enrollment forecasts and manage cross-functional dependencies across Regulatory, Quality, Data Management, Biostatistics, Laboratory Operations, and Medical Affairs</li> </ul>   <h3>Study Startup and Site Operations</h3> <ul> <li style="color: #000000 !important;">Lead feasibility and site selection end to end, including questionnaire development, site scoring, selection recommendations, and activation planning</li> <li style="color: #000000 !important;">Manage site contracts and budgets, confidentiality agreements, essential document collection, IRB/EC submissions, and green-light criteria through site initiation</li> <li style="color: #000000 !important;">Monitor 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 sites</li> <li style="color: #000000 !important;">Refer scientific, protocol interpretation, and referral network matters to the Medical Science Liaison and Head of Clinical Development</li> </ul> <h3>Vendor and CRO Management</h3> <ul> <li style="color: #000000 !important;">Manage CRO and vendor selection, scopes of work, contracts, change orders, invoicing, and accruals</li> <li style="color: #000000 !important;">Govern vendor performance against defined KPIs and service level agreements, lead governance meetings, and initiate corrective action when deliverables are at risk</li> <li style="color: #000000 !important;">Coordinate central laboratory, IRT, EDC, eCOA, imaging vendors, and clinical supply and logistics</li> </ul> <h3>Budget and Resource Oversight</h3> <ul> <li style="color: #000000 !important;">Manage study budgets and resource plans, track forecast versus actual spend, and maintain accruals</li> <li style="color: #000000 !important;">Identify variances early and present leadership with options and the associated cost and schedule trade-offs</li> </ul> <h3>Quality, Compliance, and Documentation</h3> <ul> <li style="color: #000000 !important;">Maintain trial master file completeness and inspection readiness on an ongoing basis</li> <li style="color: #000000 !important;">Partner with Quality Assurance on deviations, CAPAs, audits, and inspection preparation</li> <li style="color: #000000 !important;">Ensure study conduct is compliant with ICH-GCP, applicable regulations, and internal SOPs, and coordinate the operational elements of safety reporting with Pharmacovigilance</li> <li style="color: #000000 !important;">Develop and maintain standardized project management templates, working practices, and operating cadences that support consistent execution across studies</li> </ul> <h3>Meeting and Data Review Operations</h3> <ul> <li style="color: #000000 !important;">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 closure</li> <li style="color: #000000 !important;">Manage data cleaning timelines, query resolution, and database lock readiness so that scientific review proceeds on schedule</li> <li style="color: #000000 !important;">Translate protocol and clinical objectives into executable operational plans, monitoring strategies, and resourcing models</li> </ul> <h3>Field Presence</h3> <ul> <li style="color: #000000 !important;">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</li> </ul> <h2>QUALIFICATIONS</h2> <ul> <li style="color: #000000 !important;">Bachelor's degree in a life science or related field required; advanced degree (MS, PharmD, PhD) preferred</li> <li style="color: #000000 !important;">Minimum of 5 years of clinical research experience, including at least 3 years managing oncology trials in a program or project management capacity</li> <li style="color: #000000 !important;">Demonstrated accountability for at least one oncology study from startup through database lock preferred</li> <li style="color: #000000 !important;">Working knowledge of ICH-GCP, applicable FDA regulations, IRB/EC processes, and trial master file and inspection readiness requirements</li> <li style="color: #000000 !important;">Proficiency with CTMS, eTMF, EDC, and IRT systems, project management tools such as Smartsheet or MS Project, and Microsoft Office</li> <li style="color: #000000 !important;">Experience managing CRO and site contracts, budgets, and change orders</li> <li style="color: #000000 !important;">Experience within small- to mid-sized biotechnology companies preferred</li> <li style="color: #000000 !important;">PMP or equivalent project management certification preferred</li> </ul> <h2>KNOWLEDGE, SKILLS, AND ABILITIES</h2> <ul> <li style="color: #000000 !important;">Ability to work independently, take ownership of outcomes, and maintain progress under competing priorities and compressed timelines</li> <li style="color: #000000 !important;">Ability to operate without an established playbook, adapting plans as the science, portfolio, and business continue to evolve</li> <li style="color: #000000 !important;">Willingness to engage at a detailed operational level and resolve obstacles proactively</li> <li style="color: #000000 !important;">Reliance on data, including enrollment curves, cycle times, query aging, and vendor performance metrics, to identify root causes of delay and test assumptions</li> <li style="color: #000000 !important;">Ability to guide cross-functional initiatives and build alignment across clinical, medical, and product organizations</li> <li style="color: #000000 !important;">Clear, direct written and verbal communication, including the ability to brief senior leadership concisely and hold vendors accountable to commitments</li> <li style="color: #000000 !important;">Builds and sustains effective working relationships internally and externally</li> </ul> <ul> <li style="color: #000000 !important;">Requires working with PHI (Protected Health Information) in paper and electronic formats, treating regulatory and quality requirements as foundational</li> <li style="color: #000000 !important;">Completes HIPAA/PHI privacy, compliance, and security training within 30 days of hire and maintains current status on Natera training requirements</li> </ul>  <div class="content-pay-transparency"><div class="pay-input"><div class="description">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.</div><div class="title">Remote USA</div><div class="pay-range">$116,200—$145,200 USD</div></div></div><div class="content-conclusion">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 <a href="http://www.natera.com/" data-cke-saved-href="http://www.natera.com/">www.natera.com</a>. 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: <a href="https://www.natera.com/notice-of-data-collection-california-residents" target="_blank">https://www.natera.com/notice-of-data-collection-california-residents/</a> Please be advised that Natera will reach out to candidates with a @<a href="http://natera.com/" target="_blank" data-saferedirecturl="https://www.google.com/url?q=http://natera.com&source=gmail&ust=1657718972773000&usg=AOvVaw3zRwaIiu7070kJKNG4hjRm">natera.com</a> 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. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: - <a href="https://www.bbb.org/article/tips/12261-bbb-tip-employment-scams" target="_blank">BBB announcement on job scams</a>  - <a href="https://www.fbi.gov/investigate/cyber" target="_blank">FBI Cyber Crime resource page</a> </div>

Clinical Program Operations Manager, Therapeutics & Innovation

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