Director, Data Management

🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $165k - $175k / year

⏰ Full Time

🔴 Lead

👔 Director

👻 Ghost score 0%

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Direct Biologics

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2016

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Direct Biologics is a leader in the field of regenerative medicine, developing next-generation biologic products with a focus on Extracellular Vesicle (EV) products derived from adult human mesenchymal stem/stromal cells. These EV products offer clinical therapeutic potential and are a result of Direct Biologics' commitment to profound expertise in cellular and regenerative therapies. The company operates as a cGMP manufacturer, delivering cutting-edge clinical and scientific insights through extensive research. Direct Biologics is dedicated to revolutionizing the treatment of human diseases, leading the market with innovative regenerative biologic solutions.

📋 Description

• 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, including Data Management Plans, Data Transfer Agreements, and Data Review Plans • 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 trial documents, including Protocols, Monitoring Plans, Statistical Analysis Plans, and Clinical Study Reports • 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

🏖️ Benefits

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