Senior Oncology Trials Lead — Global CTM & Operations

Precision Point; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Precision Point seeks a Senior Clinical Trial Manager to lead oncology trials from startup through database lock in a fast-growing biotech setting. You will own operational delivery for one or more global studies, driving timelines, budgets, vendor performance and site engagement to ensure quality and regulatory compliance.

The role requires 8–10 years in clinical research with oncology focus, and experience leading multi-site trials, managing CROs and budgets. Travel up to 20% is expected.

Qualifications

• Bachelor's degree in life sciences, nursing or related field.
• 8–10 years of clinical research experience with oncology focus.
• 4+ years in a CTM or study lead role.
• Oncology clinical trial experience is required.
• Experience leading global or multi-site trials across phases.
• Knowledge of ICH GCP and FDA regulations.

Responsibilities

• Lead the operational execution of Phase 1 through Phase 3 oncology trials, accountable for timelines, quality and budget from protocol development through clinical study report.
• Serve as the primary operational point of contact for the cross functional study team, including Clinical Development, Medical Monitoring, Biostatistics, Data Management, Regulatory, Safety and CMC.
• Select, contract and manage CROs and specialty vendors, holding them accountable to scope, deliverables and KPIs.
• Drive study startup activities including site feasibility, site selection, regulatory document collection, IRB and ethics submissions, and site activation.
• Develop and own study plans, including the clinical monitoring plan, risk management plan, enrollment and retention strategy, and communication plan.
• Monitor enrollment and site performance against plan, identifying risks early and implementing mitigation strategies to keep the program on track.
• Build strong relationships with investigators, site staff and key opinion leaders in oncology, supporting investigator meetings and site engagement initiatives.
• Manage study budgets and forecasts, review and approve vendor and site invoices, and support contract and budget negotiations with sites.
• Oversee Trial Master File completeness and inspection readiness, and ensure all activities comply with ICH GCP, FDA regulations and company SOPs.
• Partner with Data Management on data review, query resolution and database lock timelines.
• Contribute to protocol, informed consent, CRF and study manual development and amendments.
• Mentor and provide day to day direction to Clinical Trial Managers, CRAs and Clinical Trial Associates on the study team.
• Present study status, risks and metrics to Clinical Operations leadership and senior management.

Skills

Clinical trial leadership

Vendor management

Cross-functional collaboration

Regulatory compliance

Budget management

Education

Bachelor's degree in life sciences, nursing or related field

Advanced degree (MS, MPH, PharmD, PhD or RN)

Tools

CTMS

EDC

eTMF

IRT

Job description

Precision Point seeks a Senior Clinical Trial Manager to lead oncology trials from startup through database lock in a fast-growing biotech setting. You will own operational delivery for one or more global studies, driving timelines, budgets, vendor performance and site engagement to ensure quality and regulatory compliance.

The role requires 8–10 years in clinical research with oncology focus, and experience leading multi-site trials, managing CROs and budgets. Travel up to 20% is expected.