Clinical Quality Assurance Compliance Specialist

3 days ago

Bikaner, Rajasthan, India beBeeQuality Full time ₹ 90,00,000 - ₹ 1,50,00,000

Job Title: Clinical Quality Assurance Compliance Specialist

This role will oversee end-to-end clinical trial activities from a quality perspective. The successful candidate will be accountable for ensuring quality compliance across various teams, including Clinical Trial Medical Science, Operations, Clinical Trial Supply Management, and Clinical Data Management.

The primary objective of this position is to establish procedures and trainings that safeguard human subjects from research risk, ensure data reliability and integrity, and maintain internal consistency and quality compliance measures.

To achieve this goal, the candidate will develop and implement a risk-based approach to quality compliance within the function. This will involve identifying team members' specific SOP training requirements, maintaining oversight of training, and preparing SOPs related to the QC function.

Responsibilities will include quality review of clinical trial medical science-related activities, such as synopsis, protocol, clinical study reports, and appendices, in line with ICH GCP requirements and Indian and global regulatory requirements.

The ideal candidate will have a strong eye for detail, excellent conflict management skills, and experience in handling audits and inspections by DCGI and US FDA. They will also possess thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations.

A minimum of 5 years' experience in a CRO/Pharma/Biotech organization in the Quality department, with experience of quality activities in Clinical Research, is required.

Strong analytical skills and attention to detailExperience in quality assurance and complianceExcellent communication and interpersonal skillsAbility to work effectively in a matrix environment

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