Clinical Quality Assurance Compliance Specialist

1 day ago


Allahabad, Uttar Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

Clinical Quality Assurance Compliance Manager

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Job Title: Clinical Quality Assurance Compliance and Training Specialist

Experience: 5+ years

Location: Mumbai

Type: Full-time

Experience Level: [Senior] Manager/Senior Manager

Department: Clinical Research Department

Purpose of this Role:

This role will be responsible for end-to-end oversight of clinical trial activities from a quality perspective. The role will ensure compliance with applicable regulations and guidelines, guaranteeing 24x7 inspection/audit readiness.

The successful candidate will establish procedures and training programs to safeguard human subjects from research risks and ensure data integrity and internal consistency.

Key Responsibilities:

• Develop and implement risk-based quality compliance within the function

• Identify team member's job-specific SOP training requirements

• Prepare SOPs related to QC function and review SOPs specific to Medical Science, Clinical Team, and Data Management Team

• Conduct quality reviews of clinical trial medical science-related activities

• Review clinical trial operation-related activities and documentation

Required Skills and Qualifications:

• Minimum 5 years' experience in Quality department with experience of Quality activities in Clinical Research Department

• Strong eye for detail and ability to spot inconsistencies

• Good conflict management skills

• Experience in handling audits & inspections of DCGI, US FDA

• Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials



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