Clinical Trials Operations Manager

Astera Cancer Care; East Brunswick Township (NJ); On-site; USD 120,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits

401(k) with company contribution

Tuition assistance

Employee referral bonus

Paid time off

Job summary

Astera Cancer Care is seeking a Manager of Research Operations to oversee the integrity, quality, and compliance of clinical trials across our network in New Jersey and Pennsylvania. You will supervise coordinators, refine workflows, and ensure accurate data collection and risk management under study protocols.

You will lead protocol reviews, safety monitoring, and sponsor interactions while coordinating audits and regulatory inspections to uphold patient welfare and research excellence.

Qualifications

• Bachelor’s degree in biology, life sciences or equivalent.
• At least 5 years of clinical research experience.
• Supervisory experience preferred.

Responsibilities

• Supervise clinical research coordinators, ensuring efficient workload distribution and adherence to regulatory and protocol requirements.
• Collaborate cross-functionally to design and refine workflows and SOPs for quality and efficiency in trial operations.
• Manage site qualification, initiation, and close-out visits with study sponsors to support trial execution.
• Review protocols and informed consent documents to ensure understanding of objectives, methodology, and safety.
• Oversee subject screening based on medical history and protocol criteria.
• Ensure visits comply with protocol requirements and conduct necessary procedures and testing.
• Oversee IP inventory, accountability, and reconciliation across sites.
• Ensure timely data collection and entry into sponsor systems and internal databases.
• Serve as liaison with sponsor representatives and monitors for protocol inquiries.
• Lead review of protocol amendments and safety notices with staff.
• Coordinate sponsor monitor visits and assist with preparations.
• Act as SME for investigational product administration and safety profiles.
• Conduct feasibility assessments and assist with enrollment screening as needed.
• Support sponsor audits, FDA inspections and internal quality reviews.

Skills

Clinical research experience

Supervisory experience

Education

Bachelor’s degree in biology/life sciences

Job description

Astera Cancer Care is seeking a Manager of Research Operations to oversee the integrity, quality, and compliance of clinical trials across our network in New Jersey and Pennsylvania. You will supervise coordinators, refine workflows, and ensure accurate data collection and risk management under study protocols.

You will lead protocol reviews, safety monitoring, and sponsor interactions while coordinating audits and regulatory inspections to uphold patient welfare and research excellence.