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Description

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.

Requirements

Some required skills for the Scientist position:

• 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

Primary Roles and 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

 Qualifications:

• 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

Benefits

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