Parexel Hiring Clinical Data Analyst

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