Clinical Development - Data Analyst

Biological E; Hyderabad; Presencial; INR 800.000 - 1.200.000; Jornada completa

Descripción de la vacante

Biological E in India is seeking a Clinical Research Regulatory professional to ensure GCP compliance and site readiness for trials. The role involves audits, document review, and regulatory inspections coordination, with travel up to 40% to clinical sites.

Strong English communication and organizational skills are essential. The successful candidate will oversee Trial Master File reviews, ensure data integrity, and support SOP updates and regulatory responses as part of a robust quality and

Formación

• Extensive knowledge of ICH GCP and CDSCO guidelines.
• Experience in regulatory inspections is advantageous.
• Proficient in MS Word, Excel, PowerPoint.
• Excellent written and verbal English.
• Strong organizational and problem-solving abilities.
• Willing to travel up to 40%.
• Effective time management.

Responsabilidades

• Ensure availability of essential documents for a clinical study prior to initiation.
• Conduct GCP compliance audits at clinical sites to verify qualifications, resources, and procedures.
• Review the Trial Master File for accuracy and completeness.
• Review the clinical study report for compliance and consistency with data.
• Support SOP updates and process improvements.
• Assist in preparation and response to audits and regulatory inspections.

Conocimientos

GCP & CDSCO guidelines

Regulatory inspections experience

MS Word, Excel, PowerPoint

English communication

Organizational skills

Time management

Willingness to travel

Descripción del empleo

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.