Director of Data Management & Systems (Stock Options)

Direct Biologics; Austin (TX); Hybrid; USD 110,000 - 190,000; Full time

Benefits offered by this job

Health care plan

Company 401k match

Paid time off

Holidays

Stock option

Job summary

Direct Biologics in Austin, TX is seeking a Senior Data Management Scientist to lead DM activities in compliance with ICH/GCP and SOPs. You will develop DM documents, design and oversee EDC, and manage DM processes and standards for clinical trials.

The role emphasizes collaboration with regulatory, quality assurance, and cross-functional teams to ensure data integrity and timely trial deliverables. A strong background in life sciences and data systems is essential.

Qualifications

• BA/BS in life sciences or related field is required.
• 10+ years of relevant industry experience.
• Experience managing department personnel.
• Experience with relevant EDC systems.
• Proficiency in Microsoft Office 365.

Responsibilities

• Execute DM activities and deliverables in accordance with ICH/GCP guidelines and SOPs.
• Develop and approve DM documents (e.g., DMP, DTAs, DRP).
• Design and develop Electronic Data Capture (EDC).
• Oversee and coordinate EDC integrations.
• Develop and maintain a standard Case Report Form library.
• Provide SME to protocols, monitoring plans, SAPs, and CSRs.
• Identify, mitigate, and manage data management risks.
• Develop DM SOPs with Clinical Operations and QA.
• Oversee DM external service providers.

Skills

FDA regulations

ICH-GCP guidelines

Clinical research process

Cross-functional communication

Issue identification & solutions

Organization & time management

Education

BA/BS in life sciences

Tools

EDC systems

Microsoft Office 365

Job description

Direct Biologics in Austin, TX is seeking a Senior Data Management Scientist to lead DM activities in compliance with ICH/GCP and SOPs. You will develop DM documents, design and oversee EDC, and manage DM processes and standards for clinical trials.

The role emphasizes collaboration with regulatory, quality assurance, and cross-functional teams to ensure data integrity and timely trial deliverables. A strong background in life sciences and data systems is essential.