Director, Data Management & Regulatory Excellence

Direct Biologics; Austin (TX); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

401k Match

Paid Time Off

Holidays

Stock Options

Job summary

Direct Biologics, a cGMP manufacturer, seeks an experienced Data Management Lead to drive DM activities across clinical programs in the US. You will design EDC systems, develop data management plans, and coordinate with Clinical Operations and QA to ensure ICH/GCP compliance.

Ideal candidates have a BA/BS in life sciences and 10+ years in data management within clinical research, with strong cross-functional communication and leadership abilities.

Qualifications

• BA/BS in a life sciences field.
• 10+ years of relevant industry experience.
• Experience managing department personnel.
• Experience with relevant EDC systems.

Responsibilities

• Execute DM activities per ICH/GCP and SOPs.
• Develop/approve DM documents (DMP, DTAs, DRP).
• Designs and develops Electronic Data Capture (EDC).
• Oversees EDC integrations.
• Maintain standard Case Report Form library.
• Provide SME input for trial documents (Protocols, SAPs).
• Identify and mitigate DM risks.
• Develop and implement DM SOPs with Clinical Ops & QA.
• Manage external DM service providers (ESPs).
• Represent DM to regulatory authorities when needed.
• Apply industry best practices to DM systems.
• Lead, train, mentor DM staff.
• Other duties as assigned.

Skills

FDA regulations

ICH-GCP guidelines

Clinical research process

Cross-functional communication

Issue identification & solutions

Time management

Education

Bachelor's degree in life sciences

Tools

EDC systems

Microsoft Office 365

Job description

Direct Biologics, a cGMP manufacturer, seeks an experienced Data Management Lead to drive DM activities across clinical programs in the US. You will design EDC systems, develop data management plans, and coordinate with Clinical Operations and QA to ensure ICH/GCP compliance.

Ideal candidates have a BA/BS in life sciences and 10+ years in data management within clinical research, with strong cross-functional communication and leadership abilities.