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Senior Clinical Quality Assurance Lead

3 weeks ago

Madurai, Tamil Nadu, India beBeeClinical Full time

Job Summary

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We are seeking a seasoned expert to lead our Clinical Quality Assurance efforts. This role involves conducting GCP audits, providing consultations, and supporting clinical trial activities. The ideal candidate will have significant decision-making authority on clinical quality matters and ensure the efficient operation of the QA department.

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Main Responsibilities

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  • Conduct GCP audits and provide consultations:">
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    • Perform on-site and virtual audits of clinical investigator sites, processes, documents, and vendors including CROs, central labs, IVRS, and data management.">
    • Offer expert consultations and clinical trial support to R&D teams.">
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  • Serve in an advisory role for R&D:">
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    • Advise Clinical Operations, Clinical Development, Statistics, Programming, Regulatory Affairs, Pharmacovigilance, and other R&D functions.">
    • Review and provide feedback on clinical documents including protocols, consent forms, monitoring plans, and data management plans.">
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  • Quality Assurance Activities:">
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    • Oversight of quality assurance activities related to clinical, bioanalytical, diagnostic, safety, and pharmacokinetics analyses of clinical studies.">
    • Ensure all activities comply with GCP guidelines and regulatory requirements.">
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  • Lead GCP Inspection Readiness Activities:">
    • ">
    • Preparation for and leadership of GCP inspection readiness activities, including preparation, hosting, and responding to findings from regulatory inspections.">
    • Development and implementation of strategies to maintain continuous inspection readiness.">
    ">
  • Decision Making on Clinical Quality Matters:">
    • ">
    • Exercising significant decision-making authority on clinical quality matters, including addressing serious GCP breaches.">
    • Providing guidance and recommendations for resolving quality issues.">
    ">
  • Support Quality Management System (QMS):">
    • ">
    • Authoring and reviewing Clinical Quality Assurance (CQA) Standard Operating Procedures (SOPs).">
    • Reviewing and ensuring alignment of functional area SOPs with GCP and regulatory standards.">
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  • Collaboration and Communication:">
    • ">
    • Working closely with cross-functional teams to ensure alignment and compliance with GCP.">
    • Providing training and mentorship to team members on GCP and quality assurance practices.">
    ">
  • Continuous Improvement:">
    • ">
    • Identification of areas for improvement in clinical processes and practices.">
    • Development and implementation of corrective and preventive actions (CAPAs) to enhance quality and compliance.">
    ">
  • Leveraging International Experience:">
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    • Utilization of extensive experience working with US and European companies to navigate and comply with varying regulatory requirements.">
    • Facilitating global clinical trials and ensuring adherence to multinational GCP standards.">
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Requirements

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  • Master's or bachelor's degree in a relevant field.">
  • 12- 15 years of experience in clinical research quality assurance or a related field.">
  • Extensive knowledge of GCP guidelines and regulatory requirements.">
  • Proven experience in conducting GCP audits and inspections.">
  • Strong analytical and problem-solving skills.">
  • Excellent communication and interpersonal skills.">
  • Ability to work independently and as part of a multidisciplinary team.">
  • Certification in GCP or related areas is a plus.">
  • Extensive experience working with US and European companies.">
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Why choose us?

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We offer a collaborative and dynamic work environment that fosters growth and development. Our team is passionate about delivering high-quality results and making a meaningful impact in the industry.

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About this role

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This is a challenging and rewarding opportunity for an experienced professional to take on a leadership role in our Clinical Quality Assurance department. If you are motivated by the prospect of driving quality excellence and advancing our mission, we encourage you to apply.

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