Senior Manager of Clinical Compliance

2 days ago

Alwar, Rajasthan, India beBeeClinical Full time ₹ 20,00,000 - ₹ 30,00,000

Job Title: Senior Manager of Clinical Quality Assurance and Training

Experience:

  • 5 plus years in a CRO/Pharma/Biotech organization in the Quality department with experience of Quality activities in Clinical Research department.

Purpose of this Role:

The Senior Manager will be responsible for oversight on end-to-end clinical trial activities from a quality perspective. Ensuring that all study-related activities, processes, procedures, and adherence to applicable regulations and guidelines are in place to ensure 24x7 Inspection/audit readiness is key.

Key Responsibilities:

  • 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:

  • 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.

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