The Senior Clinical Database Developer (SCDD) is responsible for independently developing the clinical databases in the Electronic Data Capture (EDC) systems including programming of edit checks/rule/dynamics/alerts etc. in support of Emerald Clinical (GC) research projects to ensure the collection of complete and accurate data for final analysis. The SCDD role is expected to demonstrate excellent technical skills with respect to usage of EDC systems, strong analytical skills, excellent attention to detail and efficient communication skills.
Responsibilities
- Act as the Lead DB Developer (DBD) for the allocated studies by being the primary POC where the responsibilities include but are not limited to
- Participate in the KOM/review protocols and draw plans to develop databases independently
- Actively liaise with the stakeholders (external and internal) to determine study requirements, deliverables and timelines
- Build eCRF screens as required by the schedule of events in the protocol.
- Program advanced level edit checks, custom functions, dynamics and setup rules and alerts as per the Edit Check Specifications (ECS)
- Setup specific functionalities such as Randomization and Trial Supply Management (RTSM), Coding, Data Migrator etc. as necessary Contribute to the development of Database Specifications and ECS
- Demonstrate ability to make study DBs live on time to the satisfaction of all stakeholders
- Perform user and site management and maintain active users list
- Develop reports to assist cross functional teams/sites/Other as necessary
- Achieve Mid Study Updates (MSU) when necessary to the satisfaction of stakeholders,
by performing the impact analysis and making updates in the database
- Contribute to the process of external data integration when necessary
- Develop Non-CRF Data Specifications, RTSM Specification/Guidelines when necessary
- Perform database lock (interim/final) in consultation with PDD and other stakeholders by tracking the study progress and ensuring the necessary stepsare complete for DB lock
- Demonstrate ability to quickly learn and work with new EDC tools when necessary
- Effective communications with cross-functional project teams
About You
- Tertiary qualifications in Technical/Clinical Research or a related field Experience of minimum three EDC tools, for instance RAVE, Merative Zelta, Medrio, Oracle Clinical or other web-based data capture tools is preferable.
- Experience of a minimum of 10 years of DB development experience demonstrating strong technical skills, building complex clinical databases out of which three years as lead DB developer
- 4 - 5years of experience in Custom Functions is mandatory
- Minimum 8 years experience in the CRO/Pharma setting and 5 years as a Database Developer
- Knowledge of Good Clinical Practice (GCP) and applicable regulatory guidelines, especially as related to data handling and processing Ability to evaluate and recommend changes to existing processes and procedures for greater effectiveness
Locations
Locations: Bangalore, India
Remote status: Hybrid
Department Data Science Role Senior Clinical Database Developer
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