Job Title: Clinical Data Services Specialist – EDC Build
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 7–11 Years
Function: Clinical Data Services | Clinical EDC Build
Job ID: AIOC-S01623119
Company: Accenture
Accenture is seeking a highly experienced Clinical Data Services Specialist to join its Life Sciences R&D division in Bengaluru. This role focuses on Clinical EDC build and database development, supporting global clinical trials across multiple therapeutic areas. The position is well-suited for professionals with strong hands-on experience in clinical database design, EDC platforms, and regulatory-compliant data management processes.
You will play a critical role in ensuring high-quality, compliant, and reliable clinical trial data that supports regulatory submissions and successful study outcomes.
Design, build, and maintain clinical study databases in compliance with study protocols, specifications, and regulatory requirements
Develop electronic Case Report Forms (eCRFs) and program edit checks according to approved data management plans
Perform database testing, validation, and unit testing to ensure data accuracy and system integrity
Support protocol amendments and database updates through formal change control processes
Manage and configure clinical data systems including EDC, IVRS/IWRS integrations, and laboratory data administration
Ensure timely delivery of database build milestones while meeting quality and compliance standards
Collaborate with cross-functional stakeholders including Clinical Operations, Biostatistics, and Regulatory teams
Support data standards and best practices across global clinical data services engagements
Establish and maintain strong client relationships while managing multiple stakeholders
Handle project challenges, resolve issues, and deliver under tight timelines
Education
Master’s degree (MSc) in Life Sciences, Clinical Research, or a related scientific discipline
Experience
7 to 11 years of experience in Clinical Data Management with a strong focus on Clinical EDC build
Minimum 4+ years of hands-on experience with EDC platforms such as Medidata RAVE, Inform, Oracle Clinical, and Veeva
Extensive experience in database design, edit check programming, custom function development, and unit testing
Experience with IVRS/IWRS integration and laboratory data management modules
Medidata RAVE Study Builder certification is strongly preferred
Strong expertise in Clinical Data Services and EDC build processes
Ability to manage multiple stakeholders and meet strict project deadlines
Proven capability to work under pressure in a fast-paced, global delivery environment
Strong client engagement and relationship management skills
Excellent analytical, problem-solving, and communication abilities
High attention to detail with a strong quality and compliance mindset
Accenture is a global professional services leader with capabilities across digital, cloud, and security. With deep industry expertise in over 40 industries, Accenture delivers Strategy & Consulting, Technology, Operations, and Accenture Song services. Through its Advanced Technology and Intelligent Operations centers worldwide, Accenture supports leading biopharmaceutical organizations across research, clinical development, pharmacovigilance, regulatory services, and patient-focused solutions.
Work on global, high-impact clinical trials for leading biopharma organizations
Gain exposure to advanced clinical data technologies and global delivery models
Accelerate your career in Clinical Data Services and Life Sciences R&D
Be part of an inclusive, innovation-driven workplace with continuous learning opportunities
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