Parexel Hiring Clinical Data Analyst- apply online

Location: Hyderabad

Responsibilities:

Data Validation (Cleaning):

• Lead or support data cleaning and data review activities, such as query management and manual/SAS listing reviews.
• Lead or support 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 DM documents, ensuring proper documentation per Standard Operating Procedures, 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 as required.

Data Tracking and Entry:

• Track and review CRFs. Support data entry as needed.

Project Quality Management & Compliance:

• Ensure compliance with Standard Operating Procedures, ICH/GCP Guidelines.
• Lead or support functional QC activities on databases and/or patient data as per business needs.

Training:

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

Skills:

• Strong problem-solving skills and logical reasoning.
• Commitment to first-time quality with a methodical, analytical, and accurate approach to work activities.
• Effective 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 quickly learn new technologies and processes, sharing knowledge as needed.
• 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 potential prior experience in Microsoft Office Products (basic computer skills).
• Basic understanding of data management processes and data validation flow (e.g., data cleaning, DB lock).
• Basic understanding of relevant ICH-GCP Guidelines, local regulatory requirements, and PAREXEL SOPs and study-specific procedures.
• Basic knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, Datalabs, ClinBase).
• Basic 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.

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