Job Title: Clinical Data Management Expert
Location: [Insert Location]
Main Purpose of the Role
The Clinical Data Management Expert serves as the subject matter expert (SME) for clinical databases and data management, ensuring the integrity and accuracy of clinical trial data. This role is responsible for translating business needs into technical requirements, developing and maintaining data management systems, and leading data cleaning and locking efforts for regulatory submissions.
Main Responsibilities
1. Data Management Subject Matter Expertise
Project Team Collaboration: Attend Clinical Project Team meetings to gather business requirements and translate them into technical requirements for the database.
Partnering Across Functions: Collaborate with shared services such as Safety, Core Lab, and other departments to define business needs and develop technical requirements for data management.
Issue Resolution: Analyze and resolve complex data issues by working with the project team and shared services, using sound judgment and problem-solving skills.
End-User Training: Provide training to internal and external users on database systems and maintain an automated training system.
Training Records: Capture and maintain records of database and system training for team members.
Audit Support: Assist in FDA and Quality audits involving Clinical Databases and Data Management.
Document Development: Lead the development and quality control of essential data management documents like data management plans, data review guidelines, and database validation protocols.
Standards Compliance: Ensure adherence to data management standards, best practices, and Standard Operating Procedures (SOPs) for all data management activities.
2. Development and Maintenance of Clinical Database Systems
Collaboration with Technical Teams: Work closely with DM Management, Database Developers, and Programmers to deliver data management systems and solutions, including EDC, edit checks, reporting, and study notifications.
Requirements Translation: Convert business requirements into technical specifications for eCRFs, edit checks, study notifications, and database customizations.
Testing and Validation: Perform and document functional and/or user acceptance testing on study databases, ensuring quality control of data systems.
Communication: Effectively communicate timelines, deliverables, and issues with the Clinical Project Team and stakeholders.
Prioritization: Work with the Data Management team to prioritize tasks and manage project timelines.
3. Data Management Standards and System Improvements
Database Access and Security: Manage database access accounts and review them regularly to ensure integrity and security.
Process Improvements: Recommend improvements to clinical data management practices and technologies, including solutions for issues with tools or systems.
Standard Utilization: Work with Biostatistics and Programmers to ensure correct utilization of data management standards in the database and system.
4. Data Cleaning and Freeze/Lock Process
Data Review Meetings: Lead meetings with the Clinical Project Team and Biostatistics to identify data cleaning issues and strategize solutions.
Timeline Management: Plan interim and final database locks, ensuring that data management tasks are completed on time and any issues are addressed proactively.
Data Review Coordination: Oversee data review tasks, including running validation procedures, issuing queries, performing database quality control (QC), and managing SAE reconciliation, medical coding, and closure activities.
Tool Design: Design tools and reports to assist with data review and cleaning efforts.
Freeze and Lock Coordination: Lead and document data freeze activities in coordination with the Clinical Project Team, Biostatistics, and SAS programmers.
Data Issue Resolution: Use SQL and database tools to identify and resolve data issues efficiently, working closely with the Clinical Project Team.
Qualifications
Education:
Bachelor’s degree in Life Sciences, Computer Science, or a related field.
Advanced certifications or training in clinical data management is a plus.
Experience:
Minimum Experience: 3+ years of experience in clinical data management, including hands-on experience with EDC, database design, and data validation.
Technical Skills: Proficiency in data management systems, SQL, and other relevant technologies for data review and analysis.
Regulatory Knowledge: Familiarity with industry regulations and standards, including ICH-GCP, and experience supporting audits and regulatory submissions.
Key Skills:
Strong problem-solving and analytical skills.
Ability to manage and prioritize multiple tasks in a fast-paced environment.
Excellent communication and collaboration skills with internal and external stakeholders.
Detail-oriented with a strong focus on data integrity and quality control.
This role offers an exciting opportunity for a data management professional to lead critical processes in clinical trials, ensuring the quality and accuracy of data for regulatory submissions and the success of clinical studies. If you're passionate about data integrity and are ready to take on a leadership role in clinical data management, we encourage you to apply.
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