Director, Data Management
New
D
Direct BiologicsBiotechnology
Austin, Texas, United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 10+ years of relevant industry experience
- Required Skills
- Data management
Requirements
- BA/BS in life sciences or a relevant field.
- 10+ years of relevant industry experience.
- Strong knowledge of FDA regulations and ICH-GCP guidelines.
- Thorough knowledge of the clinical research process.
- Experience managing department personnel.
- Experience with relevant EDC systems.
- Proficiency in Microsoft Office 365.
- Ability to identify issues and independently assess and recommend solutions.
- Strong interpersonal, communication, and cross-functional collaboration skills.
- Strong organizational, prioritization, and time management skills.
Responsibilities
- Execute DM activities and deliverables in compliance with ICH/GCP guidelines and SOPs.
- Develop and approve DM documents such as Data Management Plans and Data Review Plans.
- Design and develop Electronic Data Capture (EDC) systems and coordinate their integrations.
- Develop and maintain standard Case Report Form library.
- Provide subject matter expertise for clinical trial documents including protocols and Statistical Analysis Plans.
- Identify, mitigate, and manage risks related to 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.
- Lead, train, and mentor DM personnel.
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