Clinical Data Analyst III

Parexel; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Parexel is seeking an experienced Clinical Data Analyst III to independently lead clinical data validation and data management activities across studies. The role requires SME-level expertise in data review, reconciliation, and QA, with mentoring responsibilities for junior analysts.

You will manage data queries, support UAT for database setups, ensure compliance with ICH-GCP and regulatory requirements, and collaborate with sponsors and cross-functional teams across global studies.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Experience in Clinical Data Management within CROs or sponsors.
• Familiarity with ICH-GCP guidelines.

Responsibilities

• Lead clinical data validation, cleaning, review, and reconciliation across studies.
• Manage data queries and listings reviews (manual and SAS-generated).
• Perform data reconciliation of external vendor data to ensure integrity.
• Identify risks and support mitigation planning and timeline input.
• Lead UAT activities for clinical databases and configurations.
• Mentor junior Clinical Data Analysts and act as SME for data management tools.

Skills

Leadership & Mentoring

Stakeholder Management

Data Validation & Reconciliation

CDMS Knowledge (EDC)

Problem Solving

Communication

Education

Bachelor's degree in Life Sciences or related discipline

Tools

Medidata Rave

Oracle InForm

Veeva

DataLabs

ClinBase

Job description

Job Summary

We are seeking an experienced Clinical Data Analyst III (CDA III) to independently lead clinical data validation and data management activities across clinical studies. The role requires expertise in clinical data review, reconciliation, database quality control, risk identification, study start-up support, and cross-functional collaboration. The successful candidate will act as a Subject Matter Expert (SME), mentor junior team members, and contribute to process improvements while ensuring compliance with ICH-GCP guidelines and regulatory requirements.

Key Responsibilities

• Independently perform and lead clinical data validation, cleaning, review, and reconciliation activities throughout study conduct and database lock.
• Manage data queries and conduct manual and SAS-generated listing reviews.
• Perform reconciliation of external vendor data and ensure data integrity across systems.
• Identify project risks, highlight delivery concerns, and support mitigation planning.
• Support the preparation and maintenance of Data Management documentation and Trial Master File records.
• Lead User Acceptance Testing (UAT) activities for clinical database setups.
• Review study protocols, EDC screens, and database configurations.
• Provide input into data management timelines and coordinate operational activities during study start-up.
• Track and review CRFs and support data entry activities as required.
• Perform quality control reviews and ensure compliance with SOPs, ICH-GCP guidelines, and regulatory requirements.
• Act as a mentor and provide on-the-job training to Clinical Data Analysts.
• Serve as a Subject Matter Expert (SME) for data management tools, systems, and processes.
• Support continuous improvement initiatives and implementation of project-specific tools and efficiencies.
• Provide operational metric analysis and support scope change assessments and resource planning.
• Act as backup to the Data Management Lead when required.

Required Skills

• Strong leadership and collaboration skills with the ability to coordinate global and virtual teams.
• Ability to independently interact with sponsors and stakeholders regarding data issues and study requirements.
• Strong negotiation, influencing, and stakeholder management skills.
• Advanced problem-solving and root cause analysis capabilities.
• Exceptional attention to detail and commitment to first-time quality.
• Strong organizational, prioritization, and time-management skills.
• Excellent written and verbal communication skills.
• Effective presentation and knowledge-sharing abilities.
• Adaptability and ability to work in dynamic, fast-paced environments.
• Strong mentoring and coaching skills.

Technical Requirements

• Strong experience with Clinical Data Management Systems such as Medidata Rave, Oracle InForm, Veeva, DataLabs, or ClinBase.
• Advanced understanding of clinical data management processes, including data cleaning, reconciliation, and database lock activities.
• Expertise in database setup activities and data validation specifications.
• Knowledge of MedDRA and WHODrug coding dictionaries.
• Understanding of CDISC standards.
• Basic knowledge of SAS and programmed listings.
• Strong knowledge of ICH-GCP guidelines, clinical research regulations, and industry best practices.
• Experience leading virtual data management teams across global studies.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related healthcare discipline.
• Relevant experience in Clinical Data Management within the clinical research or CRO industry.