Job Description

This is an opportunity to join a science-driven organization focused on advancing precision medicine for patients with both common and rare diseases. The Clinical Trial Manager (CTM) will play a key, hands-on role in supporting the execution of clinical programs in Chronic Kidney Disease (CKD).

In this position, you will contribute to mid- to late-stage clinical studies, working cross-functionally with internal stakeholders and external partners to ensure studies are executed efficiently, on time, and in compliance with quality and regulatory standards. This role is well-suited for someone who enjoys being deeply involved in trial execution, collaborating across functions, and helping bring innovative therapies to patients.

Key Responsibilities

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  Lead or co-lead the execution of one or more Phase 2 clinical trials in CKD, overseeing activities from protocol development through key milestones such as first patient in (FPI), interim analysis, database lock, and clinical study report completion.
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  Oversee and manage external partners, including CROs, vendors, and global clinical sites.
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  Ensure study conduct aligns with protocols, SOPs, and regulatory requirements, including ICH-GCP, through oversight of site monitoring and trial activities.
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  Support the development and review of key study documents, including CRFs, informed consent forms (ICFs), and patient-facing materials.
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  Represent Clinical Operations on cross-functional teams, including participation in Study Execution Team (SET) meetings.
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  Collaborate with Clinical Operations and Clinical Science to support engagement with key opinion leaders (KOLs) and investigators.

Qualifications & Experience

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  Bachelor's degree or higher in a scientific or healthcare-related field.
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  At least 4 years of clinical research experience, including a minimum of 2 years in a Clinical Trial Manager role within a biotech, pharma company, or CRO environment.
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  Experience supporting early to mid-stage clinical trials (Phase I–II preferred).
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  Demonstrated ability to manage clinical trials from study start-up through close-out.
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  Working knowledge of FDA regulations and ICH-GCP guidelines.

Core Competencies

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  Strong organizational and project management skills, with the ability to manage multiple priorities simultaneously.
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  Clear and effective verbal and written communication skills.
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  Proven problem-solving and negotiation capabilities.
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  Ability to build and maintain strong relationships across internal teams and external partners.
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  Willingness to take a hands-on approach and contribute across a wide range of clinical operations activities.
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  Flexibility to travel as required based on study needs.

Technical Skills

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  Proficiency in Microsoft Office tools (Excel, Word, PowerPoint, Outlook, Project).
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  Experience working with clinical trial systems such as Medidata Rave, Veeva, or similar platforms.