Senior Clinical Database Developer

This is a fully remote position, open to applicants in India.

📋 Description

• Independently design clinical databases within Electronic Data Capture (EDC) systems for clinical research initiatives.

• Serve as the Lead Database Developer and main point of contact for assigned studies.

• Engage in kick-off meetings, examine protocols, and strategize database development.

• Collaborate with internal and external stakeholders to ascertain study requirements, deliverables, and timelines.

• Construct eCRF screens in accordance with protocol schedules of events.

• Program advanced edit checks, custom functions, dynamics, rules, and alerts based on Edit Check Specifications.

• Establish Randomization and Trial Supply Management (RTSM), Coding, Data Migrator, and other necessary functionalities.

• Contribute to Database Specifications, Edit Check Specifications, Non-CRF Data Specifications, and RTSM specifications/guidelines.

• Ensure that study databases are operational on schedule and meet stakeholder expectations.

• Manage user and site operations and uphold active user lists.

• Generate reports for cross-functional teams and sites.

• Conduct impact analysis and execute Mid Study Updates.

• Assist with external data integration.

• Execute interim and final database locks in coordination with relevant stakeholders.

⛳️ Requirements

• Tertiary qualifications in Technical/Clinical Research or a relevant field.

• Preferably, experience with at least three EDC tools, such as RAVE, Merative Zelta, Medrio, Oracle Clinical, or other web-based data capture tools.

• A minimum of 10 years of database development experience showcasing strong technical skills, including three years in a lead database developer role.

• 4–5 years of mandatory experience in Custom Functions.

• At least 8 years of experience in the CRO/Pharma environment and 5 years serving as a Database Developer.

• Familiarity with Good Clinical Practice (GCP) and relevant regulatory guidelines, particularly regarding data handling and processing.

• Capacity to assess and suggest modifications to existing processes and procedures for enhanced effectiveness.

• Exceptional technical skills with EDC systems.

• Strong analytical abilities and keen attention to detail.

• Effective communication skills.

• Ability to swiftly learn and adapt to new EDC tools when required.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package reflecting your skills and experience.

• Flexibility: Enjoy hybrid or remote working arrangements based on your location and role.

• Career Growth: Access to extensive learning opportunities and a global network of scientific leaders to support your professional development.

• Employee Wellbeing: Programs and initiatives fostering work-life balance, health, and team connectivity, including global engagement surveys, recognition programs, and team-building events.

• Global Opportunities: Experience diverse projects and clients through the company’s international reach.