Senior Clinical Trial Manager

Position Overview

We are seeking a Senior Clinical Trial Manager to lead the execution of oncology clinical trials from study startup through database lock and close out. This person will own the operational delivery of one or more global studies, driving timelines, budgets, vendor performance and site engagement while ensuring quality and compliance with ICH GCP.

The ideal candidate brings 8 to 10 years of clinical research experience, a strong track record in oncology, and the confidence to operate as the operational lead for a study team in a fast moving, growth stage biotech environment. This role reports to the Senior Director of Clinical Operations.

Key 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 (central labs, imaging, IRT, ECG, biomarker and PK labs), 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

Required Qualifications

• Bachelor's degree in life sciences, nursing or a related field
• 8 to 10 years of clinical research experience in the biotech, pharmaceutical or CRO industry, including at least 4 years in a clinical trial management or study lead role
• Oncology clinical trial experience is required, with hands on management of solid tumor or hematologic malignancy studies
• Proven experience leading global or multi site trials across multiple phases, ideally including first in human or dose escalation studies
• Demonstrated success managing CROs and vendors in an outsourced model
• Strong working knowledge of ICH GCP, FDA regulations and oncology specific trial requirements such as RECIST, iRECIST or IWG response criteria
• Experience managing study budgets, forecasts and site contracts
• Proficiency with CTMS, EDC, eTMF and IRT systems
• Willingness to travel up to 20% for site visits, investigator meetings and vendor meetings

Preferred Qualifications

• Advanced degree (MS, MPH, PharmD, PhD or RN)
• Experience with novel oncology modalities such as cell therapy, T cell engagers, bispecific antibodies, ADCs or targeted small molecules
• Biomarker driven or precision oncology trial experience, including companion diagnostic coordination
• Prior CRA or site level experience
• Experience supporting FDA, EMA or other health authority inspections
• Background in a small to mid sized biotech where the CTM wears multiple hats
• Experience with trials in the US, EU and APAC