Data Analyst

Biological E; Hyderabad; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Biological E is seeking a Regulatory Affairs professional to ensure GCP compliance and oversee regulatory inspections at clinical sites. The role involves auditing site qualifications, resources, SOPs, and data integrity, with responsibility for document master files and study reports.

Candidate will support audit preparations, respond to regulatory inquiries, and coordinate with internal teams to drive process improvements. Travel up to 40% is required.

Qualifications

• Strong knowledge of regulatory requirements: ICH GCP & CDSCO guidelines.
• Experience in hoisting regulatory inspections at a clinical site is an advantage.
• MS Word, Excel and PowerPoint proficiency.
• Strong written and verbal communication in English.
• Strong organizational and problem-solving skills.
• Open for travelling (40% travel involved).
• Effective time management skills.

Responsibilities

• Ensure availability of essential documents for a clinical study prior to study initiation.
• Conduct GCP compliance audits at clinical sites to ensure investigator/site staff qualification, resources and procedures.
• Review Trial Master File for accuracy and sync with Site Master File.
• Review the clinical study report for compliance and data consistency.
• Support SOP updates and process improvements.
• Assist in preparation, conduct and response to audits/regulatory inspections.

Skills

Regulatory knowledge

Regulatory inspections experience

MS Office proficiency

English communication

Organizational & problem-solving

Travel readiness 40%

Time management

Job description

Desired Candidate Profile:

• Strong knowledge and skill in applying all applicable clinical research regulatory requirements; i.e., International Conference on Harmonization (ICH) GCP & CDSCO guidelines.
• Experience in hoisting any regulatory inspection at a clinical site is an advantage.
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint.
• Strong written and verbal communication skills including good command over English language.
• Strong organizational and problem-solving skills.
• Open for travelling (40% of travel involved)
• Effective time management skills

Responsibilities:

1. Ensure availability of essential documents for a clinical study prior to study initiation.

2. Conduct GCP compliance audits at clinical sites to ensure:

I. Investigator & site staff qualification & experience

II. Adequacy of resources

III. Adequacy of written procedures or instructions at site

IV. Subject safety

V. Data reliability

VI. Consistency and compliance in data collection process and records maintenace

VII. e-CRF completion and consistency with source documents

VIII. Investigational drug supply and accountability

3. Review the Trial Master File to ensure accuracy and completeness of the documentation in sync with the Site Master File.

4. Review the clinical study report to ensure compliance with relevant standards/regulations and consistency with data generated during the study.

5. Support process improvements and review of procedures (SOP) updates as needed.

6. To support the preparation, conduct and response to internal and external audits/regulatory inspections.