Director, Data Management

All regulated processes adhere to cGxP standards, guaranteeing the utmost safety and quality at every phase of product development.

About Direct Biologics

• Direct Biologics is a science-based market leading innovator and certified cGMP manufacturer of regenerative biologic products driven by science and innovation.
• Our company is dedicated to delivering cutting-edge clinical and scientific solutions through meticulous research efforts.
• Direct Biologics prioritizes patient safety above all else.
• Direct Biologics delivers high-quality products for healthcare providers and patients alike.
• Our commitment to excellence is upheld through our quality systems, ensuring the consistent provision of safe products.
• Direct Biologics was established with the goal of advancing the frontier of cutting-edge human cell and tissue technologies.
• Our company has amassed substantial intellectual property focused on stem cell secretomes and their applications.

Responsibilities

• Successful and timely execution of DM activities and deliverables in compliance with International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)
• Develops and/or approves DM documents (e.g., Data Management Plan, Data Transfer Agreements, Data Review Plans, etc.)
• Designs and develops Electronic Data Capture (EDC)
• Oversees and coordinates EDC integrations

Develops and maintains standard Case Report Form library

• Provides subject matter expertise to the development of other trial documents (e.g., Protocols, Monitoring Plans, Statistical Analysis Plans, Clinical Study Reports, etc.)
• Proactively identifies, mitigates, and manages risk in data management issues.
• Develops and implements DM SOPs in partnership with Clinical Operations and Quality Assurance

Manages DM external service providers (ESPs)

• Represents DM in interactions with regulatory authorities, as needed
• Applies current industry best practices to DM systems and processes
• Leads, trains and mentors DM personnel
• Performs other duties as assigned

Requirements

• Strong knowledge of FDA regulations and ICH-GCP guidelines

Thorough knowledge of the clinical research process

• Strong interpersonal skills with the ability to effectively communicate cross-functionally at all levels of the organization, as well as externally with stakeholders and ESPs
• Ability to identify issues and independently assess and recommend specific solutions
• Strong organizational skills, prioritization, time management, and cross functional collaboration
• BA/BS in life sciences relevant field, preferable.
• 10+ years of relevant industry experience
• Experience managing department personnel
• Experience with relevant EDC systems
• Proficiency in Microsoft Office 365

Pay

Salary: USD 165,000–175,000

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Company 401k match up to 4%
• Paid Time Off (Vacation & Sick)
• Holidays
• Stock Option

Director, Data Management

Direct Biologics · Austin, United States (Remote) · Full-time · Posted 2026-09-22

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[Apply at Direct Biologics](https://apply.workable.com/direct-biologics/j/24A1E2BEBC/apply)