Associate Director, Clinical Data Management

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Clinical Data Management leader to guide global Phase I–IV studies in autoimmune-focused therapies, including CAR T platforms.

You will oversee end-to-end data management, protocol reviews, EDC/CRF design, data validation, and CDISC-based submissions, partnering with CROs and regulatory teams to ensure data quality and timely filings. Strong cross-functional collaboration and GxP compliance are essential.

Qualifications

• Bachelor's degree in life/health sciences.
• 8+ years in clinical data management within pharma/biotech.
• Extensive experience leading global studies, managing CROs, and working with EDC and regulatory submissions.

Responsibilities

• Oversee end-to-end data management processes: protocol review, EDC/CRF design, data validation.
• Lead cross-functional reviews and vendor performance for timely regulatory submissions.

Skills

Clinical data management

Global study leadership

Regulatory submissions

EDC

CDISC standards

Vendor/CRO oversight

Education

Bachelor's degree in life/health sciences

Tools

EDC systems

CDISC standards

Job description

Role

Senior Clinical Data Management leader supporting global Phase I-IV studies in a biotech focused on autoimmune disease therapies, including CAR T-cell platforms like CABA-201 for SLE, myositis, and systemic sclerosis.

Responsibilities

• oversee end-to-end data management processes-protocol review, EDC and CRF design, data validation, vendor oversight, database lock, regulatory submissions, and compliance with GxP, FDA, and ICH standards.
• Lead cross-functional reviews, develop data plans, manage CRO/vendor performance, and contribute to quality and process improvements.

Qualifications

• Bachelor's in life/health sciences;
• 8+ years in clinical data management within pharma/biotech;
• extensive experience leading global studies, managing CROs, and working with EDC, CDISC standards, and regulatory submissions.

High-Value

• autoimmunity
• biologics
• cell therapy
• Phase I-IV
• GxP compliance
• CDISC standards
• cross-functional leadership
• vendor oversight
• regulatory support.

Work Setup

remote with possible cross-functional collaboration.