Parexel Clinical Data Analyst Job – Apply Online
Clinical Data Analyst II
Location: Hyderabad, India
Job ID: R0000029152
Category: Data Management
About this Role
The Clinical Data Analyst II (CDA II) performs all clinical data validation activities on assigned projects with minimal guidance and supervision from the Line Manager and/or Subject Matter Expert. Responsibilities include supporting data validation activities, managing Data Management documents, and data cleaning matrices such as Data Validation Specification, CRF Completion Guidelines, Protocol Deviation Specification, and Mock Shells for Off-line listings.
All tasks should be performed in accordance with corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP, and other international regulatory requirements.
Data Validation (Cleaning)
- Lead/Responsible for data validation (cleaning/review/reconciliation) activities during conduct and database lock (Primary CDA), such as query management, manual/SAS listing reviews, and external vendor data reconciliation.
Data Management Documents/Plans (Trial Master File)
- Perform and/or support the setup of Data Management (DM) documents and ensure proper documentation per Standard Operating Procedures and ICH/GCP Guidelines.
Study Start-Up Activities and User Acceptance Testing (UAT)
- Lead/perform user acceptance testing on clinical database setups.
- Review protocols and EDC Entry Screens if required.
- Provide input on data management timelines and coordinate DM operational activities during database setup.
- Track and review CRFs; support data entry where required.
Project Quality Management & Compliance
- Ensure compliance with Standard Operating Procedures, ICH/GCP Guidelines.
- Perform/Lead functional QC activities on databases and/or patient data, as per business needs.
Training
- Maintain training compliance as per Job Roles assigned, including On-the-Job training.
- Address training needs according to Development Goals identified.
- Provide relevant on-the-job training to staff and project teams.
- Act as Mentor for other clinical data analysts.
Skills:
- Strong problem-solving skills and logical reasoning
- Commitment to first-time quality with attention to detail
- Time management and prioritization skills to meet objectives and timelines
- Evidence of collaborative team work
- Ability to coordinate and prioritize tasks for the team in the Primary CDA role
- Good interpersonal, oral, and written communication skills
- Swift learning and knowledge-sharing approach
- Flexibility with work assignments and new learning opportunities
- Accountability to Key Accountabilities as outlined in the Job Description
- Fluency in written and spoken English
Knowledge and Experience:
- Strong technical aptitude with awareness or prior experience in Microsoft Office Products
- Good understanding of data management processes and data validation flow (e.g., Data cleaning, DB lock)
- Knowledge of ICH-GCP Guidelines, local regulatory requirements, Parexel SOPs, and study-specific procedures
- Familiarity with Clinical Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs, ClinBase)
- Understanding of Clinical Study Team roles within Data Management
- Clinical research industry experience
- Knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG)
- Understanding of Data Management Operational processes for study start-up, conduct, and close-out
- Familiarity with Database setup activities, including Database Configuration Specifications and Data Validation setup
- Basic knowledge of SAS (programmed listings)
- Understanding of Data standards (CDISC)
Education:
- Bachelor’s degree and/or other medical qualifications or relevant industry experience.
Location: Hybrid – Bengaluru/Hyderabad/Mumbai/Mohali
Got Hired Through Biotecnika? Let us know by clicking here and win some prize!
Keywords: Parexel, Clinical Data Analyst II, Hyderabad, Data Management, Clinical Research, Clinical Data Validation. Parexel Clinical Data Analyst Job – Apply Online. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
