▌Position Description:
The Applications Support Engineer is a specialized role in the field of clinical research. This role is responsible for providing technical support and expertise for electronic data capture (EDC) systems and related applications utilized in clinical research studies. The Applications Support Engineer plays a crucial role in ensuring the efficient functioning of EDC systems and the accurate collection and management of clinical trial data.
▌Key Responsibilities:
1. Collaboration with Study Teams:
▪ Work closely with study teams, including clinical investigators, project managers, and statisticians, to gain a deep understanding of data collection requirements and study protocols.
▪ Collaborate with stakeholders to define data standards and ensure alignment with study objectives.
2. Design and Configure eCRFs:
▪ Utilize expertise in data management and EDC systems to design and configure electronic case report forms (eCRFs).
▪ Ensure that eCRFs are tailored to specific study requirements, capturing all essential data points necessary for analysis.
▪ Collaborate with study teams to customize eCRFs according to study protocols and objectives.
3. User-Friendly eCRFs:
▪ Pay special attention to user-friendliness when designing eCRFs to facilitate ease of use for clinical site personnel and data entry personnel.
▪ Implement user-friendly features such as clear instructions, data validation checks, and logical data entry flows.
▪ Continuously gather feedback from end-users to improve eCRF design and usability.
4. Utilize Programming Languages and EDC-Specific Tools:
▪ Proficiently use programming languages such as SQL, SAS, R, and EDC-specific tools to develop custom functionalities and edit checks.
▪ Implement these custom functionalities to ensure data accuracy, consistency, and compliance with data standards.
5. Testing and Issue Resolution:
▪ Conduct thorough testing of eCRFs, edit checks, and data capture processes to identify and promptly resolve any issues or discrepancies.
▪ Collaborate with the study team to ensure the reliability and integrity of collected data.
6. Data Collection and Entry:
▪ Develop data collection tools and electronic data capture (EDC) systems.
▪ Oversee and ensure the accurate and timely entry of clinical trial data.
▪ Monitor data collection processes to identify and address discrepancies and issues.
7. Data Validation and Cleaning:
▪ Implement data validation checks and edit checks to identify errors and inconsistencies in collected data.
▪ Collaborate with clinical site personnel to resolve data queries and discrepancies.
▪ Maintain data integrity and quality throughout the trial.
▌Qualificaions:
▪ Bachelor’s degree in biological science or a related field.
▪ Ability to plan, multitask and work in a dynamic team environment.
▪ Strong verbal and written communication skills.
▪ Excellent computer skills, including proficiency in MS Office (Word, Excel, PowerPoint, Office, Project).
▪ Ability to manage and prioritize workload effectively.
