Clinical Trial Manager

Summary

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

• 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.
• Oversee and manage external partners, including CROs, vendors, and global clinical sites.
• Ensure study conduct aligns with protocols, SOPs, and regulatory requirements, including ICH-GCP, through oversight of site monitoring and trial activities.
• Support the development and review of key study documents, including CRFs, informed consent forms (ICFs), and patient-facing materials.
• Represent Clinical Operations on cross-functional teams, including participation in Study Execution Team (SET) meetings.
• Collaborate with Clinical Operations and Clinical Science to support engagement with key opinion leaders (KOLs) and investigators.

Qualifications & Experience

• Bachelor's degree or higher in a scientific or healthcare-related field.
• 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.
• Experience supporting early to mid-stage clinical trials (Phase I–II preferred).
• Demonstrated ability to manage clinical trials from study start-up through close-out.
• Working knowledge of FDA regulations and ICH-GCP guidelines.

Core Competencies

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

Technical Skills

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