Clinical Trial Manager

Clinical Trial Manager

Greater NYC Area - Hybrid

Compensation: $150,000-155,000 + 15% bonus + Lucrative Stock Options Package + 4 Weeks PTO and 2 company shutdowns per year (6 weeks total PTO)

Company Summary:

A cutting-edge biotech company that's revolutionizing drug discovery using Nobel Prize-winning science is currently building out its Clinical Operations team ahead to support its highly anticipated Phase 3 study. Their technology allows scientists to watch proteins move in real time inside living cells, offering a deeper understanding of disease and drug effects. With AI and automation, they analyze millions of cells daily, driving a robust pipeline that includes a lead candidate entering Phase 3 for an Oncology indication, along with programs in neurology and immunology. Backed by over $1.1 billion in funding and led by industry veterans behind some of the most impactful therapies in recent years, this is a unique chance to join a team poised to become a major force in pharma. Don't hesitate to apply to learn more.

Primary Responsibilities:

• Partner with Clinical Study Operations to provide strategic direction and hands-on oversight for the internal execution of global clinical research studies, ensuring timely, cost-effective delivery of high-quality data.
• Design and implement operational strategies to support the successful internal management of oncology-focused clinical trials.
• Work closely with cross-disciplinary teams-including data science, medical affairs, regulatory affairs, and clinical investigators-to drive operational excellence and accelerate the generation of reliable study outcomes.
• Oversee all trial initiation activities, coordinating with internal teams responsible for site engagement, monitoring, and vendor performance to streamline site selection, feasibility evaluations, and study documentation preparation.
• Collaborate with internal monitoring and site engagement teams to ensure efficient site activation, training, and oversight, maintaining compliance with study protocols, regulatory standards, and international clinical research guidelines.
• Foster strong working relationships with clinical sites, including investigators and site staff, to support patient enrollment and retention efforts.
• Track study milestones and performance metrics, proactively identifying risks or deviations and implementing corrective measures to preserve study integrity and timelines.
• Ensure adherence to global regulatory standards, including ICH-GCP and applicable health authority requirements, throughout the study lifecycle.
• When needed, coordinate with third-party service providers such as CROs, labs, and imaging vendors to ensure timely and quality deliverables.
• Contribute to the drafting and review of essential study materials, including protocols, informed consent documents, case report forms, and internal procedural documents.
• Prepare operational tools and workflows to ensure consistent adherence to study plans and administrative processes.
• Lead the organization and maintenance of essential study documentation, including oversight of the central trial file and site-level records.
• Conduct regular audits and reviews of the sponsor's trial documentation to ensure completeness, accuracy, and regulatory compliance.

Ideal Qualifications:

• Experience working on Oncology Trials
• Experience working in an FSP model
• Experience working on trials in an insourced model where you were responsible for interacting directly with clinical trial sites.
• Experience being a CTM for at least 5 years