Role Purpose

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 George

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.

Key accountabilities

• 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

o Participate in the KOM/review protocols and draw plans to develop

databases independently

o Actively liaise with the stakeholders (external and internal) to determine

study requirements, deliverables and timelines

o Build eCRF screens as required by the schedule of events in the protocol.

o Program advanced level edit checks, custom functions, dynamics and

setup rules and alerts as per the Edit Check Specifications (ECS)

o Setup specific functionalities such as Randomization and Trial Supply

Management (RTSM), Coding, Data Migrator etc. as necessary

o Contribute to the development of Database Specifications and ECS

o 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 steps

are complete for DB lock

• Demonstrate ability to quickly learn and work with new EDC tools when

necessary

• Effective communications with cross-functional project teams

Education and Experience

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
• Minimum 8 years’ experience in the CRO/Pharma environment 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