Clinical Program Operations Manager, Therapeutics – Innovation

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $116.2k - $145.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

📋 Program Manager

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Natera

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

📋 Description

• Deliver oncology clinical trials operationally, managing timelines, budgets, vendors, sites, and data flow • Develop and maintain integrated study timelines, critical paths, Gantt charts, dashboards, milestone reports, and risk and issue logs • Identify risks, drive mitigation plans, and escalate issues with recommended actions • Develop enrollment forecasts and manage dependencies across Regulatory, Quality, Data Management, Biostatistics, Laboratory Operations, and Medical Affairs • Lead feasibility, site selection, activation planning, contracts, budgets, essential documents, IRB/EC submissions, and site initiation • Monitor site performance and implement corrective action plans • Manage CRO and vendor selection, scopes of work, contracts, change orders, invoicing, accruals, KPIs, and service level agreements • Coordinate central laboratory, IRT, EDC, eCOA, imaging vendors, clinical supplies, and logistics • Manage study budgets, resource plans, forecast versus actual spend, and accruals • Maintain trial master file completeness and inspection readiness • Partner with Quality Assurance on deviations, CAPAs, audits, and inspection preparation • Ensure compliance with ICH-GCP, regulations, and internal SOPs; coordinate operational safety reporting with Pharmacovigilance • Lead logistics for investigator meetings, site visits, monitoring visits, steering committee meetings, and data review meetings • Manage data cleaning, query resolution, and database lock readiness • Translate protocols and clinical objectives into operational plans, monitoring strategies, and resourcing models • Travel to clinical sites, CROs, investigator meetings, and partner locations to oversee execution and resolve operational issues

🎯 Requirements

• Bachelor's degree in a life science or related field required • 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, IRT systems, 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 • Willingness to travel up to approximately 25% • Ability to work with PHI and complete HIPAA/PHI privacy, compliance, and security training within 30 days of hire

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and dependents • Free testing for employees and immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401(k) benefits • Commuter benefits • Employee referral program