Senior Clinical Trial Manager (ACH)

Scorpion Therapeutics; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Clinical Trial Manager to support rare disease trials from start-up through close-out. The role involves managing CROs, vendors, and sites, coordinating study setup, and ensuring regulatory compliance across GCP, ICH, and FDA standards.

The position emphasizes strong project management, independence, and experience with eTMF, CTMS, and EDC systems, with remote work and periodic in-person collaboration, and minimal travel.

Qualifications

• 8+ years of clinical trial support experience, including 3+ years as CTM/Sr. CTM for early-phase/global trials.
• Bachelor's degree in life sciences or equivalent.
• Strong project management skills and ability to work independently.
• Proficiency with electronic trial systems (eTMF, CTMS, EDC) and regulatory guidelines.

Responsibilities

• Oversee CROs, vendors, and site activities for global studies.
• Coordinate study setup: protocols, systems, regulatory submissions.
• Ensure adherence to GCP, ICH, and FDA requirements.
• Maintain documentation, support audits, and monitor study metrics.

Skills

Project management

Independent work

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's in life sciences

Tools

eTMF

CTMS

EDC

Job description

Role

Senior Clinical Trial Manager supporting rare disease clinical trials, overseeing study start-up through close-out.

Responsibilities

• manage CROs, vendors, and sites;
• coordinate study setup including protocols, systems, and regulatory submissions;
• ensure compliance with GCP, ICH, FDA regulations;
• maintain documentation, assist with audits, and support study metrics.

Requirements

• Bachelor's in life sciences;
• 8+ years clinical trial support experience, with at least 3 years in a CTM/Sr. CTM role overseeing early phase and global trials;
• strong project management skills;
• proficiency with electronic trial systems (eTMF, CTMS, EDC);
• knowledge of regulatory guidelines;
• ability to work independently.

High-Value

rare disease, clinical trial management, global early-phase studies, regulatory compliance, eTMF/CTMS systems.

Work Setup

remote with periodic in-person collaboration; minimal travel (~5-10%).