Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities.
Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process.
Review the protocol and associated study reference materials to contribute to the development of the clinical database design project timeline. Maintain database design timelines and promote good project management practices.
Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training and/or relevant association activities.
Design and review case report forms (CRFs/eCRFs) and setup electronic data capture (EDC) systems for clinical trials.
Author and review the Data Validation Specifications for assigned projects.
Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers. Coordinate and oversee the UAT process for clinical databases.
Design and review patient Case Report Forms and database schema. Test data capture/entry screens through UAT.
Participate in EDC vendor’s technical learning and exchange meetings as well as other internal and external training meetings.
Participate in trial Investigators Meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control Processes.
Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systems.
Provide input to all data management procedural documents.
Plan, manage, control and perform data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements.
Review the Data Management Plan (DMP) for assigned projects.
Review data, issue and resolve queries. Assist the Lead Data Manager, sponsor or Investigative Site with resolving queries.
Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products.
Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate real-time study monitoring reports to sponsor and internal team members.
Define and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines.
Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.
Participate in and contributes to Clinical Data Management initiatives.
Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports.
B.Sc. in Biological Sciences or Computer Science.
Five years' related experience.
Two to three years developing Inform and/or Medidata Rave (or similar) clinical data bases. Previous Clinical Data Management experience in both paper based and electronic data capture systems.
Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels.
Proven leadership and interpersonal skills in complex team situations.
Excellent presentation skills and the ability to build relationships with both internal and external clients.
Must be well organized and able to work independently and manage multiple projects/tasks appropriately.
Demonstrated ability to effectively organize and integrate the activities of information processing personnel.