Clinical Trial Manager; CTM​/Sr. CTM

RONDO THERAPEUTICS CLINICAL TRIAL MANAGER (CTM)/Sr. CTM

Rondo Therapeutics is a privately held clinical‑stage biotechnology company committed to advancing the field of immuno‑oncology with a focus on treating solid tumors that fail to respond to current therapies. Our solution is to create a new class of bispecific antibodies that safely engage the immune system to initiate and sustain a robust anti‑tumor response.

Rondo was launched in 2021 by experienced entrepreneurs in the field of immuno‑oncology. Rondo has raised Series A financing led by a world‑class syndicate of investors to support the growth of our Hayward, California‑based research site.

POSITION SUMMARY

The Clinical Trial Manager (CTM)/Sr. CTM will provide operational and technical expertise to help plan and execute one or more of Rondo’s oncology first‑in‑human phase 1 global clinical trials. This role will be responsible for overseeing all aspects of daily operations of the clinical trial, including management and oversight of the clinical research organization (CRO). The ideal candidate will have extensive, hands‑on experience working in a dynamic fast‑paced environment.

As Rondo advances its first oncology asset into Phase 1 clinical trials, we are seeking a talented, experienced, and highly motivated CTM/Sr.CTM to join our oncology Clinical Operations team. The candidate must have the ability to work independently, be an effective leader, and act as an engaged clinical study team member. You will play a key role in contributing to high‑quality in‑house clinical study management, ensuring compliance with regulatory guidelines, and contributing to planning, managing and successful completion of global clinical trials.

This is a hybrid position reporting directly to the Vice President of Clinical Operations; the CTM/Sr.CTM will partner with the cross‑functional team to contribute to the execution of the clinical strategy of the company. The ideal candidate will bring strong experience in early‑phase oncology clinical trials, a collaborative management style, and a passion for advancing innovative therapies.

Key Responsibilities

• Manage global phase 1/1b clinical trial(s) to ensure that all key trial milestones and activities are completed on‑time and within budget, by managing key components of the trial.
• Contribute to the development and maintenance of key trial documents such as protocols, ICFs, study plans, etc.
• Drive the timing of critical site and trial management activities such as development of clinical trial agreements and budgets, site activations, subject enrollment, monitoring visit schedules, data entry into the electronic data capture (EDC) system, query resolution and review monitoring visit reports.
• Generate and maintain internal trial management trackers and reports.
• Monitor and manage clinical supply activities through the Interactive Response Technology (IRT) to predict the amount and timing of Investigational Product (IP) shipments to clinical sites.
• Collaborate with the Chemistry, Manufacturing and Controls (CMC) department on drug forecasting and timing of resupply(ies).
• Coordinate biosample logistics with central and third‑party labs to ensure sample delivery, resolution of queries, data transfers and support data analysis and interpretation.
• Participate in regularly scheduled CRO meetings to support management of study start‑up, maintenance, and close‑out activities.
• Manage CRO and third‑party vendors supporting clinical trials to ensure delivery against contracted scope of work and budget.
• Track timely scheduling of monitoring visits; track and review timely completion and monitoring visit reports.
• Oversee eTMF activities at CRO, including final reconciliation of eTMF prior to transfer to Rondo at study close‑out.

Clinical Trial Quality & Compliance

• Partner with CRO project lead to ensure Rondo sponsored clinical trials are conducted in accordance with ICH GCPs; contribute to any inspection readiness activities as appropriate for each phase of clinical development.
• Partner with internal and external data management lead to ensure high quality and timely data.
• Track and identify any trends or signals while performing…