Description

• Offer expertise and assist in shaping the strategy and development of Clinical Data Management Systems to maintain high data quality, supporting clinical study milestones and outcomes. Supervise and direct data management teams at the CRO, ensuring project timelines and business goals are met.
• Guide and contribute to the creation of systems and processes to secure clinical data integrity. Design and/or draft database structures, validation checks, CRF guidelines, and Data Management Plans for internal data management, following CDASH, ADaM, and SDTM frameworks.
• Collaborate across departments to streamline data collection and reporting processes. Manage and standardize the data flow from collection to delivery for analysis. Lead or support initiatives focused on process improvement and standardization.
• Draft, review, and update essential study documentation, including Data Quality Management Plans, Data Validation Plans, Data Review Plans, eCRF Completion Guidelines, and other materials to ensure consistency and quality. Act as the Data Management representative on cross-functional project and submission teams.

Requirements

• Previous Biotech/ Pharmaceutical company experience
• Strong CRO vendor management and oversight experience
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
• Understanding of FDA to ensure appropriate reporting of clinical trial data
• Excellent verbal and written communication skills