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About the Role
Direct Biologics is a leading innovator and cGMP manufacturer of regenerative biologic products. We are dedicated to delivering cutting-edge clinical and scientific solutions through meticulous research, prioritizing patient safety and adhering to cGxP standards. Our commitment to excellence ensures the consistent provision of safe, high-quality products for healthcare providers and patients.
Responsibilities
- Execute DM activities and deliverables in compliance with ICH/GCP guidelines and SOPs.
- Develop and/or approve DM documents, including Data Management Plans, Data Transfer Agreements, and Data Review Plans.
- Design and develop Electronic Data Capture (EDC) systems.
- Oversee and coordinate EDC integrations.
- Develop and maintain a standard Case Report Form library.
- Provide subject matter expertise for the development of other trial documents such as Protocols, Monitoring Plans, Statistical Analysis Plans, and Clinical Study Reports.
- Proactively identify, mitigate, and manage risks in data management issues.
- Develop and implement DM SOPs in partnership with Clinical Operations and Quality Assurance.
- Manage DM external service providers (ESPs).
- Represent DM in interactions with regulatory authorities, as needed.
- Apply current industry best practices to DM systems and processes.
- Lead, train, and mentor DM personnel.
- Perform other duties as assigned.
Requirements
- BA/BS in a life sciences relevant field is preferable.
- 10+ years of relevant industry experience.
- Experience managing department personnel.
- Experience with relevant EDC systems.
- Proficiency in Microsoft Office 365.
Skills
- 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.
Experience Level
- 10+ years of relevant industry experience
- Experience managing department personnel
Education Level
- BA/BS in a life sciences relevant field is preferable.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Company 401k match up to 4%
- Paid Time Off (Vacation & Sick)
- Holidays
- Stock Option
About the Company
- 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.
- All regulated processes adhere to cGxP standards, guaranteeing the utmost safety and quality at every phase of product development.
- 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.