This is a fully remote position, open to applicants in Texas.

📋 Description

• Efficient and timely execution of Data Management (DM) activities and deliverables adhering to International Council for Harmonisation (ICH)/Good Clinical Practice (GCP) guidelines and Standard Operating Procedures (SOPs)

• Develops and/or approves various DM documents, such as Data Management Plans, Data Transfer Agreements, and Data Review Plans

• Designs and creates Electronic Data Capture (EDC) systems

• Manages and coordinates EDC integrations

• Develops and maintains a standard library of Case Report Forms

• Provides expertise in the development of trial documents, including Protocols, Monitoring Plans, Statistical Analysis Plans, and Clinical Study Reports

• Proactively identifies, mitigates, and manages risks related to data management

• Develops and implements DM SOPs in collaboration with Clinical Operations and Quality Assurance

• Oversees external service providers (ESPs) for DM

• Represents DM in communications with regulatory authorities as necessary

• Applies industry best practices to DM systems and processes

• Leads, trains, and mentors personnel in DM

• Performs additional duties as assigned

⛳️ Requirements

• In-depth understanding of FDA regulations and ICH-GCP guidelines

• Comprehensive knowledge of the clinical research process

• Strong interpersonal skills, with the ability to effectively communicate across all levels of the organization and with external stakeholders and ESPs

• Ability to identify problems and independently evaluate and recommend specific solutions

• Excellent organizational skills, with a focus on prioritization, time management, and cross-functional collaboration

• Bachelor's degree in a life sciences-related field is preferred

• Over 10 years of relevant industry experience

• Experience in managing departmental personnel

• Familiarity with relevant EDC systems

• Proficient in Microsoft Office 365