[FRESHERS] Parexel Hiring for Clinical Data Analyst I @Bengaluru/ Hyderabad

Clinical Data Analyst I

Location:

• Bengaluru, Karnataka, India
• Additional Locations: Hyderabad, Telangana, India

Application Link

Job ID: R0000025438

Key Responsibilities:

Data Validation (Cleaning):

• Lead data cleaning and data review activities, including query management and manual/SAS listing reviews.
• Support and lead data processing activities from database setup to database lock, including external vendor data reconciliation.

Data Management Documents/Plans (Trial Master File):

• Perform and support the setup of Data Management documents, ensuring proper documentation as per SOPs and ICH/GCP Guidelines.

Study Start-Up Activities and User Acceptance Testing (UAT):

• Lead and perform user acceptance testing on clinical database setups.
• Review protocols and EDC Entry Screens as required.

Data Tracking and Entry:

• Track and review CRFs.
• Support data entry where necessary.

Project Quality Management & Compliance:

• Ensure compliance with Standard Operating Procedures and ICH/GCP Guidelines.
• 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 as identified in Development Goals.

Skills:

• Strong problem-solving skills and logical reasoning.
• Commitment to first-time quality, attention to detail.
• Time management and prioritization skills to meet objectives and timelines.
• Ability to work collaboratively within a team environment.
• Good interpersonal, oral, and written communication skills.
• Ability to learn quickly and share knowledge.
• Flexible attitude towards work assignments and new learning.
• Accountability for key responsibilities outlined in the job description.
• Fluency in English (written and oral).

Knowledge and Experience:

• Technical aptitude with basic computer skills in Microsoft Office Products.
• Basic understanding of data management processes and data validation flow.
• Familiarity with ICH-GCP Guidelines, local regulatory requirements, PAREXEL SOPs, and study-specific procedures.
• Knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, Datalabs, ClinBase).
• Understanding of Clinical Study Team roles within Data Management.
• Experience in the clinical research industry.
• Knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG).
• Awareness of Data Management Operational processes and tasks during study start-up, conduct, and close-out.
• Knowledge of Database setup activities, including Database Configuration Specifications and setup of Data Validation.

Education:

• Bachelor’s degree and/or other medical qualifications or relevant industry experience.

Work Location:

• Office-based in Bengaluru or Hyderabad.

Application Link