Clinical Quality Assurance Compliance & Training

Job Title:

Experience

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Purpose of this Role:

This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role 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. This role will be responsible for establishing the 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.

Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices.  Identify and decide team member’s job specific SOP training requirements in view of their role and maintain 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.  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.  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 & Preferred Skills

5 years’ experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department.  Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills.  Must have 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 preferred.  Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.