Oncology Clinical Programs Operations Manager

Embedded Shishya; United States; Remote; USD 116,000 - 145,000; Full time

Benefits offered by this job

Competitive benefits

Fertility care benefits

401k matching

Commuter benefits

Job summary

Natera is seeking a Clinical Program Operations Manager to lead the operational delivery of oncology trials within Clinical Innovation & Therapeutics. You will own timelines, budgets, vendor oversight, site management, and data flow to ensure studies run on schedule and inspection-ready.

You will translate approved protocols into activated sites, enrolled patients, and clean data, partnering with Medical Science Liaison, Head of Clinical Development, and cross-functional teams to drive execution

Qualifications

• Bachelor's degree in life sciences; advanced degree preferred.
• Minimum 5 years clinical research experience, including 3+ years in oncology trials in PM capacity.
• Working knowledge of ICH-GCP, FDA regulations, IRB/EC processes, TMF and inspection readiness.
• Proficiency with CTMS, eTMF, EDC, IRT, and project mgmt tools (Smartsheet/MS Project) and MS Office.
• Experience managing CROs, site contracts, budgets, and change orders.
• Experience in small- to mid-sized biotech companies preferred.
• PMP or equivalent certification preferred.

Responsibilities

• Develop and maintain integrated study timelines, critical path, and Gantt charts.
• Establish dashboards, trackers, and milestone reports for leadership.
• Identify risks and drive mitigation plans to closure.
• Lead feasibility and site selection end to end, including activation planning.
• Manage site contracts, budgets, and regulatory submissions through initiation.
• Monitor site performance and implement corrective actions for underperforming sites.
• Oversee CRO/vendor selection, scopes of work, and SLAs; coordinate central labs and eClinical vendors.
• Manage study budgets and resource plans with forecast vs actual spend.
• Maintain trial master file completeness and inspection readiness.
• Lead meetings and data review activities; ensure data flow and data cleaning milestones.
• Travel up to ~25% to sites and vendors as needed.
• Ensure study conduct is compliant with ICH-GCP and internal SOPs.

Skills

Project management

Oncology trials

Vendor management

Site management

Budgeting

GxP compliance

Education

Bachelor's degree in life science

MS/PhD preferred

PMP or PM certification preferred

Tools

CTMS

eTMF

EDC

IRT

Smartsheet

MS Project

Microsoft Office

Job description

Natera is seeking a Clinical Program Operations Manager to lead the operational delivery of oncology trials within Clinical Innovation & Therapeutics. You will own timelines, budgets, vendor oversight, site management, and data flow to ensure studies run on schedule and inspection-ready.

You will translate approved protocols into activated sites, enrolled patients, and clean data, partnering with Medical Science Liaison, Head of Clinical Development, and cross-functional teams to drive execution