Clinical Data Analyst I

1-3 years

Preffered by Company

Bangalore

10 Sept. 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Data Analyst I

Role Overview:

The Clinical Data Analyst I (CDA I) supports clinical data cleaning activities and data management tasks under the guidance of their Line Manager and/or Subject Matter Experts. This entry-level role involves assisting with data validation, processing activities, and data management documentation. The CDA I will contribute to ensuring data quality and compliance with corporate standards, SOPs, ICH-GCP, and other international regulatory requirements.

Key Responsibilities:

Data Validation and Cleaning:
- Assist in data cleaning and review activities, including query management and manual/SAS listing reviews.
- Support data processing tasks from database setup through to database lock, including external vendor data reconciliation.
Data Management Documentation and Plans:
- Help with the setup and maintenance of data management documents, ensuring documentation is accurate and compliant with SOPs and ICH/GCP guidelines.
Study Start-Up and User Acceptance Testing (UAT):
- Begin to lead user acceptance testing for clinical database setups.
- Review study protocols and Electronic Data Capture (EDC) entry screens if necessary.
Data Tracking and Entry:
- Track and review Case Report Forms (CRFs) and support data entry as needed.
Project Quality Management and Compliance:
- Ensure compliance with SOPs and ICH/GCP guidelines.
- Support or lead quality control activities on databases and patient data as required.
Training:
- Maintain training compliance for assigned job roles, including on-the-job training.
- Address training needs based on development goals and provide support to other team members as needed.

Skills:

Strong problem-solving skills and logical reasoning.
Commitment to high-quality work with attention to detail.
Effective time management and prioritization to meet deadlines.
Ability to work collaboratively within a team environment.
Good interpersonal, oral, and written communication skills.
Rapid learning ability with a knowledge-sharing approach.
Flexibility and adaptability to changing technical environments.
Accountability and adherence to job responsibilities.
Fluent in written and spoken English.

Knowledge and Experience:

Demonstrates technical aptitude with experience in Microsoft Office Products.
Basic understanding of data management processes and validation flow (e.g., data cleaning, database lock).
Familiarity with ICH-GCP guidelines, local regulatory requirements, and relevant SOPs.
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 processes during study start-up, conduct, and close-out.
Familiarity with database setup activities, including Database Configuration Specifications and data validation.

Education:

Bachelor’s degree or equivalent medical qualifications or relevant industry experience.

Location:

Office-based in Bengaluru, Hyderabad, or Mohali.

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Clinical Data Analyst I

Job Description

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