Clinical Compliance Specialist

2 days ago

Coimbatore, Tamil Nadu, India beBeeClinical Full time ₹ 12,00,000 - ₹ 20,00,000
Clinical Quality Assurance Compliance Job

The selected candidate will be accountable for Quality Compliance (QC) activities of the Clinical Trial Medical Science team, Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team.

To ensure 24/7 Inspection/Audit Readiness, we review all study-related activities, processes, procedures, and adherence to applicable regulations and guidelines. Developing and implementing a risk-based and flexible approach to Quality Compliance within the function is essential to safeguarding trial participants and data in compliance with applicable regulatory requirements and best practices.

We are seeking an experienced professional with at least 5 years' experience in a CRO/Pharma/Biotech organization in Quality departments with experience of Quality activities in Clinical Research departments.

  • Strong attention to detail and ability to spot inconsistencies is mandatory, along with good conflict management skills.
  • Must have experience handling audits and 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.

This role requires a strong track record of success demonstrated through annual performance ratings and/or professional accomplishments and awards. Preferred Skills include experience working in matrix business environments.

Key Responsibilities
  • Establishing procedures and training teams to protect human subjects from research risk, ensure reliability/integrity of data, and maintain internal consistency and Quality Compliance measures.
  • Preparing SOPs related to QC functions and supporting the review of SOPs specific to Medical Science, Clinical teams, and Data Management teams.
  • Quality reviews of clinical trial medical science-related activities, as well as SOPs aligned with ICH GCP requirements, Indian, and global regulatory requirements.
  • Quality reviews of clinical trial operation-related activities, including site feasibility, site selection visits, site initiation, Ethic Committee documentation, monitoring-site specific reports, Site Documents, logs, and close-out activities.

Qualifications:

  • Bachelor's degree in relevant field.
  • At least 5 years' experience in a CRO/Pharma/Biotech organization in Quality departments with experience of Quality activities in Clinical Research departments.

Additional Information:

  • A key responsibility will be establishing procedures and training teams to protect human subjects from research risk, ensure reliability/integrity of data, and maintain internal consistency and Quality Compliance measures.

Contact Us:

Please submit your application to apply for this position.

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