You will engage in Data Monitoring and Management (DMM) activities, including data review, query management, and investigating logic check flags.

Key responsibilities include:

• Ensuring the quality of database design through documentation, testing, validation, and implementation of clinical data collection tools or systems.
• Serving as the first Point of Contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues.
• Adhering to applicable Standard Operating Procedures (SOPs) and working practices.
• Collaborating with Study Team Points of Contact, Document Owners, and Trial Master File (TMF) Study Owners to resolve document-related discrepancies and issues.
• Contributing to process improvement initiatives and additional projects as they arise.

Requirements:

• BA/BS degree with any years of experience.
• Demonstrated experience of ICH/GCP (International Council for Harmonization/Good Clinical Practice) documentation requirements.
• Hands-on experience with electronic documentation management systems and/or web-based data management systems.
• Awareness of the clinical development process, including a deep understanding of the principles of Good Clinical Practice.
• Solid grasp of regulatory requirements and relevant data standards.
• Strong oral and written English communication skills.
• Proficiency in Microsoft Office Suite.

Preferred qualifications:

• Experience with clinical trial management systems (CTMS).
• Familiarity with data validation and quality control processes.
• Ability to work collaboratively in a team environment.
• Strong problem-solving skills and attention to detail.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot.

Work Location Assignment: Hybrid

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