Clinical Data Analyst II

Parexel; Hyderabad; On-site; INR 900,000 - 1,800,000; Full time

Job summary

Parexel in Hyderabad seeks an experienced Clinical Data Analyst with 4+ years in clinical data management. You will support data review, cleaning, CRF design, UAT, and vendor reconciliations across global trials.

You will work with cross-functional teams, ensure GCP compliance, and mentor junior CDM staff in Oncology, Hematology, Cardiovascular, Fibrosis, and Cell Therapy studies.

Qualifications

• Minimum 4+ years of experience in Clinical Data Review and Clinical Data Management.
• Hands-on experience with Medidata RAVE and other EDC systems.
• Experience supporting study build activities, including CRF design, edit checks, and integrations.
• Experience performing UAT during study build and validation phases.
• Strong experience in vendor reconciliation and external data review.
• Experience with database lock activities, including CRF freeze and lock processes.
• Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Experience working within Veeva Vault and eTMF environments.
• Experience in Oncology, Hematology, Cardiovascular, Fibrosis, and/or Cell Therapy studies preferred.
• CCDM Certification is advantageous.
• Stable employment history with tenure of at least one year with previous employers or a valid explanation for transitions.

Responsibilities

• Review clinical data listings and manage data discrepancies across trials.
• Support data review, data cleaning, and study build activities including CRF design and edit checks.
• Conduct UAT during study build and validation phases.
• Coordinate vendor reconciliations and review external data sources.
• Oversee database lock processes including CRF freeze and lock.
• Ensure compliance with ICH-GCP guidelines and regulatory requirements.
• Collaborate with cross-functional teams and mentor junior CDM staff.

Skills

Clinical Data Review

Clinical Data Management

UAT testing

Vendor reconciliation

Data cleaning

Education

Bachelor's Degree in Life Sciences/Pharmacy/Clinical Research/Biotechnology

Tools

Medidata RAVE

EDC systems

Veeva Vault

eTMF

Job description

Job SummaryWe are seeking an experienced

Job SummaryWe are seeking an experienced Clinical Data Analyst with 4+ years of clinical data management experience to support data review, data cleaning, study build activities, vendor reconciliations, and database lock processes across global clinical trials. The role will be responsible for reviewing clinical data listings, managing data discrepancies, supporting CRF (Case Report Forms) and edit check development, conducting UAT (User Acceptance Testing) activities, reviewing complex external data sources, and ensuring compliance with GCP and regulatory requirements. The successful candidate will collaborate with cross-functional teams, mentor junior CDM (Clinical Data Management) staff, and contribute to high-quality study delivery across therapeutic areas such as Oncology, Hematology, Cardiovascular, Fibrosis, and Cell Therapy. Skillsets

• Minimum 4+ years of experience in Clinical Data Review and Clinical Data Management.
• Hands-on experience with Medidata RAVE and other EDC (Electronic Data Capture) systems.
• Experience supporting study build activities, including CRF design, edit checks, and integrations.
• Experience performing UAT during study build and validation phases.
• Strong experience in vendor reconciliation and external data review.
• Experience with database lock activities, including CRF freeze and lock processes.
• Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Experience working within Veeva Vault and eTMF environments.
• Experience in Oncology, Hematology, Cardiovascular, Fibrosis, and/or Cell Therapy studies preferred.
• CCDM Certification is advantageous.
• Stable employment history with tenure of at least one year with previous employers or a valid explanation for transitions.

Qualification Bachelor's Degree in Life Sciences, Pharmacy, Clinical Research, Biotechnology, or a related field.