Clinical Data Management (Data Analyst)

QPS Bioserve; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

QPS Bioserve is seeking a Clinical Data Management specialist to design and review eCRFs, implement edit checks, and develop data management plans in line with study protocols.

You will collaborate with Clinical, Medical, Biostatistics, and Programming teams to ensure high data quality and compliance with GCP, CDISC, and regulatory requirements.

Experience with Clinion, Medidata Rave, and Oracle Clinical is essential to manage databases and support the full data lifecycle.

Qualifications

• Experience with eCRF creation and data validation.
• Proficient in edit checks, DMP preparation and data cleaning.
• Familiarity with CDISC standards and GCP.

Responsibilities

• Design, develop, and review eCRFs based on study protocols.
• Prepare and implement edit checks and data validation specs.
• Develop and maintain Data Management Plans (DMPs).
• Perform clinical data review, discrepancy management, and query generation.
• Support database build, testing, UAT, and study closeout activities.
• Collaborate with Clinical, Medical, Biostatistics, and Programming teams.
• Maintain data quality and ensure compliance with GCP, CDISC and regulatory requirements.
• Manage clinical databases using tools such as Clinion, Rave (EDC), Oracle Clinical, and other CDM platforms.

Skills

eCRF creation

edit checks

DMP preparation

data cleaning

database management

attention to detail

analytical skills

cross-functional collaboration

Tools

Clinion

Medidata Rave

Oracle Clinical

Job description

Role & responsibilities:

• Design, develop, and review eCRFs based on study protocols.
• Prepare and implement edit checks and data validation specifications.
• Develop and maintain Data Management Plans (DMPs).
• Perform clinical data review, discrepancy management, query generation, and data cleaning.
• Support database build, testing, UAT, database lock, and study closeout activities.
• Work closely with Clinical, Medical, Biostatistics, and Programming teams.
• Maintain data quality and ensure compliance with applicable GCP, CDISC, and regulatory requirements.
• Manage clinical databases using tools such as Clinion, Rave (EDC), Oracle Clinical, and other clinical data management platforms.

Requirements:

• Strong experience in eCRF creation, edit checks, DMP preparation, data cleaning, and database management.
• Experience with Crinion, Medidata Rave, Oracle Clinical, or similar EDC/CDM tools.
• Good understanding of clinical trial processes and CDM standards.
• Strong attention to detail, analytical skills, and ability to work effectively in cross-functional teams.