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About Company

PAREXEL is seeking a Clinical Data Analyst I with 6 months to 1 year of experience in clinical data management. The role involves data validation, data management, user acceptance testing, and compliance with ICH/GCP guidelines.

Position Name :

Clinical Data Analyst I

Organization :

Parexel

Qualification:

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Experience:

0 YEARS / Freshers - 1 Year

Salary:

₹4.5 Lakhs to ₹10.0 Lakhs.

Location:

Hyderabad, Bengaluru, SAS Nagar (Mohali), Punjab, India

Key Responsibilities:

Data Validation (Cleaning):

  • Responsible for or start to lead data cleaning and data review activities, such as query management and manual/SAS listing reviews.
  • Support or start to lead data processing activities, including external vendor data reconciliation.

Data Management Documents/Plans (Trial Master File):

  • Perform and/or support the setup of data management documents ensuring proper documentation per SOPs and ICH/GCP guidelines.

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

  • Lead or perform user acceptance testing on clinical database setups.
  • Review protocols and EDC entry screens if required.

Data Tracking and Entry:

  • Track and review case report forms (CRFs).
  • Support data entry as needed.

Project Quality Management & Compliance:

  • Ensure compliance with SOPs, ICH/GCP guidelines.
  • Lead functional QC activities on databases and/or patient data as per business needs.

Training:

  • Maintain training compliance per job roles assigned, including on-the-job training.
  • Address training needs as per development goals identified.

Skills Required:

  • Strong problem-solving skills and logical reasoning.
  • Commitment to first-time quality with a methodical, analytical, and accurate approach.
  • Time management and prioritization skills.
  • Ability to work collaboratively within a team environment.
  • Good interpersonal, oral, and written communication skills.
  • Learning ability and knowledge-sharing approach.
  • Flexible attitude towards work assignments and new learning.
  • Accountability relative to key accountabilities in the job description.
  • Written and oral fluency in English.

Knowledge and Experience:

  • Technical aptitude with awareness or prior experience in Microsoft Office Products.
  • Basic understanding of data management processes and data validation flow.
  • Basic understanding of ICH-GCP Guidelines, local regulatory requirements, PAREXEL SOPs, and study-specific procedures.
  • Basic 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.
  • Basic knowledge of medical terminology and coding dictionaries (e.g., MedDRA & WHODRUG).
  • Basic knowledge of data management operational processes and tasks during study start-up, conduct, and close-out.
  • Basic knowledge of database setup activities, including database configuration specifications and setup of data validation.

Application Link