Job Details

Position Overview

A growing clinical-stage oncology biotech company is seeking an experienced Clinical Trial Manager (CTM) to lead the execution of early-phase oncology clinical trials. This individual will play a critical role in managing study start-up, CRO oversight, enrollment activities, vendor management, and day-to-day trial operations across Phase 1 and Phase 2 programs.

The successful candidate will have a proven track record managing oncology studies within small biotech environments and will thrive in a fast-paced, hands-on culture where team members are expected to contribute across multiple functions. This role will initially oversee a Phase 1 study in start-up in Australia and work closely with internal and external stakeholders to ensure successful execution.

This is a contract opportunity with the potential to convert to a permanent position for the right candidate.

Key Responsibilities

• Lead the operational management of Phase 1 and Phase 2 oncology clinical trials from study start-up through closeout.
• Oversee a Phase 1 study currently entering start-up activities in Australia.
• Manage CROs, vendors, and clinical service providers to ensure delivery of study milestones, quality, and timelines.
• Track study progress, enrollment performance, site activation, and key operational metrics.
• Coordinate study start-up activities, including site selection, site initiation, regulatory submissions, and vendor implementation.
• Serve as the primary operational point of contact for internal study teams, investigators, CROs, and external partners.
• Develop and maintain study timelines, risk mitigation plans, and project tracking tools.
• Monitor study budgets, forecasts, and vendor spending in partnership with leadership and finance teams.
• Ensure protocol compliance and adherence to GCP, ICH guidelines, and company SOPs.
• Identify and proactively resolve operational challenges impacting study execution.
• Facilitate study team meetings and provide regular updates on study status, risks, and milestones.
• Support inspection readiness and audit activities as required.

Required Qualifications

• Bachelor’s degree in Life Sciences, Nursing, or a related field; advanced degree preferred.
• Significant clinical operations experience within biotechnology, pharmaceutical, or CRO organizations.
• Proven experience managing early-phase oncology clinical trials, including Phase 1 studies.
• Strong background in immuno-oncology and solid tumor clinical development.
• Demonstrated expertise in study start-up, CRO oversight, vendor management, and global study execution.
• Experience monitoring enrollment, timelines, budgets, and clinical trial performance metrics.
• Working knowledge of ICH-GCP guidelines and global clinical trial regulations.
• Excellent project management, organization, communication, and problem-solving skills.
• Ability to work independently in a remote environment while collaborating effectively across functions.

Preferred Qualifications

• Experience working within small, emerging biotechnology companies.
• Prior management of studies conducted in Australia or other global regions.
• Experience supporting Phase 1, Phase 2a, and Phase 2b oncology programs.
• Strong understanding of operational challenges unique to early-stage biotech organizations.
• Proximity to the Greater Philadelphia area and ability to attend occasional onsite meetings preferred.