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 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

Study Startup and Site Operations

• 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
• 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
• Refer 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 accruals
• Govern vendor performance against defined KPIs and service level agreements, lead governance meetings, and initiate corrective action when deliverables are at risk
• Coordinate 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 accruals
• Identify 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 basis
• Partner with Quality Assurance on deviations, CAPAs, audits, and inspection preparation
• Ensure study conduct is compliant with ICH-GCP, applicable regulations, and internal SOPs, and coordinate the operational elements of safety reporting with Pharmacovigilance
• Develop 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 closure
• Manage data cleaning timelines, query resolution, and database lock readiness so that scientific review proceeds on schedule
• Translate 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) 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

KNOWLEDGE, SKILLS, AND ABILITIES

• 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