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Responsible for ensuring the completeness, quality and integrity of the clinical databases in support of one or more areas of activities related to database setup, electronic data processing, PK/PD data handling, lab references and lab data management, data extract and reporting for all assigned studies.
Areas of activity include but are not limited to: developing data collection tools/instruments for paper or electronic study, processing and loading non-CRF/external data, evaluating new data providers for qualification, coordinating data file transferring, and managing documents from internal customer/external vendors.
Ensure the consistent use and application of applicable data standards. The ultimate objective is to ensure data quality and consistency across programs and repositories.
Ensure database management activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times.
Familiar with supported systems (data management system, EDC, etc) and able to troubleshoot and provide rapid response for all database issues.
Work with the global study team to meet the study objectives.
Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
Perform activities and provide technical expertise to set up and test data collection including but not limited to electronic data collection (EDC), case report forms (CRFs), Patient Reported Outcome (PRO), electronic data loading, PK/PD data acquisition, medical lab normal ranges, randomization and data integration, etc.
Create and write programs to assist data manager to ensure study data quality
Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
Able to resolve conflicts, influence and communicate with key stakeholders and customers.
Database Design Functions:
Design, create and test clinical database to ensure database quality.
Define investigator center assignments and patient positions in study database, and ensure consistency between the tracking database and the study database.
Ensure data collection tools and databases align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.
eData Processing & PK/PD Functions:
Work with Study Team to define the electronic data, PK/PD data, lab tests, and lab codes.
Develop Data File Specifications, PK/PD Definition Files, and translator programs, create test plan, conduct UAT testing, load eData files, and maintain documentations for electronic data receipt
Request reconciliation files from vendors and process files to retain the blind for PK/PD data management review.
Work with Central/Analytical labs and Clinical Assay Group to troubleshoot issues related to sample collection, data transfer and management.
Medical Lab Functions:
Coordinate data management and vendor interaction related to lab tests coding, unit conversion, and normal ranges setting for lab data integration, review, and reporting.
Assist project teams in lab reference range page design, screen testing, and QC.
Provide scientific knowledge and training about lab testing and clinical database to study teams, internal/external lab vendors when needed.
Enter lab normal range, unit, unit conversion into EDC or data management system
Data extract and reporting/visualization Functions:
Write, test and validate edit check programs to support data management in data cleaning and reviewing.
Evaluate/Develop/implement data review tools or data visualization tools to support data management and clinical data review.
Provide ad hoc reports requested from study teams and management for data quality, performance, progress and timeline.
Integrate study data from various sources for data management and data cleaning
Work closely with study teams, other DBMs and vendors
Create, test, validate, distribute, maintain, update and archive Randomization Schedule for CRDC study
Setup treatment schedule in data management system or EDC
Support all breaking blind activities ( unexpected or planned study close) for CRDC study
Liaise with pharmaceutical team for the drug tested.
Technical Skill Requirements
Technical expertise and business experience in supporting clinical trials database development, data acquisition, medical lab data collection (lab tests, units, and normal ranges), etc.
Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.
Bachelor’s degree or above of equivalent experience in a scientific discipline required.
Preferred Additional Experience
Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
Previous experience within a database management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, data transfer activities
Knowledge of clinical trial database and its applications
Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)