Clinical Quality Assurance Lead

4 days ago

Cochin, Kerala, India beBeeQualityCompliance Full time ₹ 15,00,000 - ₹ 25,00,000
Clinical Quality Assurance Compliance

Job Title: Clinical Quality Assurance Compliance & training.

Experience: 5 plus years of experience in a CRO/Pharma/Biotech organization in Quality department with expertise in Quality activities in Clinical Research department.

Type: Full-time role in a matrix business environment.

Department: Clinical Research Department.

Purpose of this Role:

This is a key position responsible for oversight on end-to-end clinical trial activities from a quality perspective. The successful candidate will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness.

The ideal candidate will be responsible for establishing procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures.

To achieve these goals, the candidate will develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, ensuring that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.

Responsibilities include identifying and deciding team member's job specific SOP training requirements in view of their role and maintaining oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team.

Key areas of focus include quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement.

Additionally, the candidate will be responsible for quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring – site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement.

Required Skills and Qualifications:

• 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.

• Experience of working in matrix business environments.

• Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.

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