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Clinical Data Svs Specialist

7-10 years
Not Disclosed
10 Sept. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Clinical Data Services Specialist

Location:

Bengaluru, India

Employment Type:

Full-time

Experience Required:

5–10 years

Job Number:

AIOC-S01603306

Category:

Clinical Data Management / Clinical Database Programming


About Accenture:

Accenture is a global professional services company with expertise in digital, cloud, and security solutions. It serves clients across 40+ industries, including Life Sciences, supporting clinical trials, regulatory services, pharmacovigilance, and patient services.


Job Overview:

The Clinical Data Services Specialist will be part of the Life Sciences R&D vertical. The role focuses on the collection, integration, and quality assurance of clinical trial data. Responsibilities include clinical data management (CDM), discrepancy review, query generation and resolution, creation of CRF Completion Guidelines (CCG) and SAE reconciliation guidelines, edit check validation, and database validation (UAT). The role also involves managing clinical data management projects and developing/reviewing complex reports using tools such as Cognos, SAS, and J-Review.


Key Responsibilities:

  • Perform CDM activities including discrepancy review, query generation, and resolution.

  • Develop CRF Completion Guidelines (CCG) and SAE reconciliation guidelines.

  • Identify and report protocol deviations in the database.

  • Perform edit check validation, write test scripts, and execute database validation (UAT) against CRF/eCRF.

  • Develop and review complex edit checks, patient profile listings, preprocessing checks, and map datasets for validation based on study requirements.

  • Utilize tools/technologies such as Cognos, SAS, J-Review, and other applicable systems.

  • Solve moderately complex problems and adapt existing methods/procedures to new assignments.

  • Manage small teams and/or work efforts as an individual contributor.

  • Collaborate with peers and management at client and internal levels.

  • Work under rotational shifts if required.


Qualifications:

  • BE / BTech / BSc


Skills & Competencies:

  • Commitment to quality and ability to perform under pressure.

  • Strong problem-solving, collaboration, and interpersonal skills.

  • Knowledge and experience with Clinical SAS, SQL, J-Review, and Clinical Data Warehousing (CDW).


Work Environment & Culture:

  • Equal Opportunity Employer committed to diversity and inclusion.

  • Employment decisions are made without regard to race, color, religion, gender, national origin, age, disability, or other protected characteristics.