Research Compliance Manager

Found in: Whatjobs AE C2 - 2 weeks ago

united arab emirates Cleveland Clinic Abu Dhabi LLC Full time

JOB SUMMARY

The purpose of this role is to oversee and manage the comprehensive research compliance program, ensuring adherence to Good Clinical Practice (GCP) and regulatory standards. As a key managerial figure, the incumbent will lead policy development, coordinate audits, resolve compliance issues, and drive continuous improvement initiatives, while also being responsible for the implementation and maintenance of the research regulatory and Quality Assurance (QA) program. This includes QA auditing, monitoring, training, and the development of comprehensive knowledge of research programs, encompassing sponsor-led initiatives, academic collaborations, and institutional-wide projects.

PRIMARY JOB DUTIES AND RESPONSIBILITIES

  • Lead the establishment of standard operating policies, procedures, and guidelines for research in alignment with Good Clinical Practice (GCP) and external regulatory agencies, such as the Department of Health or Ministry of Health.
  • Direct and coordinate all regulatory and research compliance quality audits and inspections for funded and unfunded studies, ensuring meticulous adherence to established protocols.
  • Identify, report, and provide managerial guidance to Principal Investigators (PI) in the resolution of compliance issues. Ensure timely reporting of findings into the quality and safety database in accordance with institutional requirements.
  • Serve as a primary liaison for the research team, offering managerial-level communication and consultation services to foster effective collaboration and heightened compliance awareness.
  • Drive continuous improvement initiatives by actively participating in the evaluation of research industry best practices. Develop and implement metrics to elevate the quality of research compliance activities.
  • Provide comprehensive education sessions to research personnel, emphasizing compliance-related matters. Foster a culture of awareness and adherence to regulatory standards.
  • Manage meticulous records, files, and data for research regulatory and quality assurance efforts. Play a pivotal role in accreditation efforts by collaborating with relevant stakeholders to meet and exceed accreditation standards.
  • Proactively collaborate with institutional stakeholders to stay abreast of changes in regulations and industry standards. Integrate regulatory updates into the research compliance framework to ensure ongoing adherence.
  • Conduct periodic reviews and assessments of internal processes to identify areas for enhancement. Provide managerial oversight to ensure alignment with evolving regulatory requirements.
  • Demonstrate flexibility and adaptability in undertaking other duties as assigned, contributing to the overall success of the research compliance program.

QUALIFICATION & EXPERIENCE REQUIREMENTS

  • Bachelor degree in relevant field (i.e. Life Sciences, Healthcare Administration, Regulatory Affairs)
  • Master’s degree in relevant field
  • Minimum 5 years of experience in a leadership or managerial role within clinical research compliance, regulatory affairs, or a related field.
  • Professional certifications in regulatory affairs, clinical research, or quality assurance (e.g., RAC, CCRP, QA certification) are highly desirable.

Job Specific Skills and Abilities

  • Must be self-directed with demonstrated ability to work independently
  • Strong leadership and managerial skills, with the ability to effectively lead coordinate compliance activities.
  • Excellent communication and interpersonal skills to facilitate collaboration and communication with internal and external stakeholders.
  • Demonstrated ability to analyze complex compliance issues, develop solutions, and drive continuous improvement initiatives.
  • Demonstrate good organizational skills and the ability to work with clinicians and others
  • Demonstrated ability in using databases, reports and data analysis
  • Thorough understanding of ICH-GCP guidelines
  • Extensive knowledge of medical terminology
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