Clinical Data Analyst III @ Parexel

Job Description

The Senior Clinical Data Analyst (SCDA) shall be responsible for data processing activities on a project and shall ensure quality standards according to SOPs and ICH-GCP. Areas of responsibility shall include data cleaning and query generation, support in data entry and CRF tracking, medical coding, SAE reconciliation and quality support on projects The CDA shall support on project meetings and telephone conferences where required. The SCDA shall act as a Project Lead on a projects where required.
Key Accountabilities
. Review the respective study protocol/CRF
. Perform data cleaning (manually or automatically) and generate DCFs.
. Perform medical coding
. Perform SAE reconciliation
. Development of project-specific status reports
. Support data entry for UAT and production
. Track and review CRFs
. Setup and review of study documents and ensure proper documentation on projects
. DM QC as assigned
. Review of study databases including data-entry screens
. Input in development of SOPs, improvement initiatives and processes
. Mentoring of staff
Skills
. Ability to work with cross-functional groups
. Ability to understand complex organizational relationships
. Willingness to work overtime
. Detail-oriented with ability to work creatively and flexible in a fast-paced environment
. Good English knowledge
. Good knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG)
. Basic knowledge of PC or Unix SAS
. Demonstrate a sound awareness of all relevant regulations, including GCPQualifications
Education
. Bachelor's degree (or equivalent) in a life science field, medical qualification (e.g. Nursing) or relevant Data Management experience
Language Skills
. Good English knowledge
Minimum Work Experience
. At least 6 years experience in a Data Management role in a clinical research environment.
. Experience in using any EDC system or SAS is preferred.

Employement Category:

Employement Type: Full time
Industry: Pharmaceutical
Functional Area: IT
Role Category: Software Engineer
Role/Responsibilies: Clinical Data Analyst III

Contact Details:

Company: Parexel International
Location(s): Bengaluru

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