Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Proficient in best practices, market trends and regulatory requirements of industry operations. Talented leader with analytical approach to business planning and day-to-day problem-solving.
• Fore fronting all operations for ensuring completeness and validity of the clinical trial data.
• Reviewing & processing clinical trial data to ensure the accuracy & consistency of clinical databases.
• Analyzing and resolving discrepancies identified by the system or through manual checks as per the data editing guidelines.
• Applying validation rules, to check for correctness & meaningfulness of data inputted to the system.
• Competently editing the database in compliance with departmental/project standards.
• Tracking and reconciling data received for in-house review through use of CRF tracking tools.
• Utilizing current study documentation including protocols, Case Report Forms (CRFs), Data Validation specifications, etc.
• Writing data clarification form and sending to the site for response.
• Taking necessary action to correct the database based on the response.
• Performing reconciliation of similar data between multiple data sources.
• Maintaining regular contact with CRAs of the sites through mail for collection of outstanding data such as CRF and data clarification forms.
• Tracking CRFs from the sites.
• Minimizing errors by implementing quality control procedure and data review tools.
• Arranging teleconference to discuss plan & issues of the project with different locations.
• Efficiently reviewing the lab data to check its correctness.
• Initiating contact with central & local labs for loading of outstanding lab data & correction of inconsistent lab data.
• Executing project tasks in accordance with project timelines and required quality standards.
• Applying corrections and updates to clinical database and appropriate documents, identified through query resolution, data entry, text review, site request, computerized validation & data importing.