Clinical Data Svs Specialist

7-11 years

Not Disclosed

Mumbai

10 Dec. 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 - Clinical Database Programming
Location: [Location not provided]

About Accenture:
Accenture is a global professional services company with capabilities in digital, cloud, and security. We offer a wide range of services across more than 40 industries, including Strategy and Consulting, Technology and Operations services, and Accenture Song. With 699,000 people serving clients in over 120 countries, Accenture is committed to driving innovation and delivering business value through technology and human ingenuity.

Job Overview:
As a Clinical Data Services Specialist, you will play a key role in clinical data management, focusing on database design, edit check programming, and the validation of clinical trial data. Your responsibilities will involve ensuring data integrity through the management of databases, performing discrepancy reviews, and generating reports using various systems and tools.

Key Responsibilities:

Manage database programming tasks, including edit check programming, custom function programming, and unit testing.
Handle integration tasks such as IVRS/RWS and Lab administration.
Develop and review complex edit checks, patient profile listings, and preprocessing checks.
Validate datasets based on study requirements using tools like Cognos, SAS, and J-Review.
Work on discrepancy review, query generation, and resolution to ensure data quality.
Create CRF Completion Guidelines (CCG) and SAE reconciliation guidelines.
Perform UAT (User Acceptance Testing) on databases for compliance with CRF/ECRF.
Manage clinical data management projects to ensure timely and accurate delivery.
Provide support and guidance to junior team members, helping resolve complex issues.
Collaborate with peers and senior management on strategy and process improvement initiatives.

Qualifications:

Education: Bachelor’s or Master’s degree in Pharmacy (B. Pharm / M. Pharm).
Experience: 7 to 11 years of experience in clinical data services and database programming.
Skills:
- Extensive experience with EDC platforms (Medidata RAVE, Inform, Oracle Clinical, Veeva, etc.).
- Proficient in database design, edit checks, and report generation.
- Experience with tools like Cognos, SAS, J-Review.
- Strong problem-solving skills, adaptability, and attention to detail.
- Ability to manage small teams or contribute as an individual contributor.
- Strong client relationship skills and ability to work under pressure.

What We Are Looking For:

Strong problem-solving and analytical skills.
Adaptability and flexibility in a fast-paced environment.
Detail-oriented with a focus on accuracy and quality.
Strong client relationship management skills.

Work Environment:

This role may require working in rotational shifts.

Apply Now:
For more information, visit Accenture Careers.

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Clinical Data Svs Specialist

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