Vacancy title:
Clinical Research Quality Manager
Jobs at:
Baylor College of Medicine Children’s Foundation -UgandaDeadline of this Job:
08 June 2022
Summary
Date Posted: Wednesday, June 01, 2022 , Base Salary: Not Disclosed
JOB DETAILS:
Job Summary
To develop and monitor the implementation of systems, policies, and procedures for continuous clinical quality improvement (CQI) across Baylor Uganda activities.
Overall Responsibilities
• Developing the site’s Clinical Quality Management Plan (CQMP) and making revisions, as needed, and submitting it to the CRS leader for review and approval;
• Reviewing the CQMP bi-annually with the CRS Leader; and making recommendations for changes to the CQMP, if needed;
• Implementing the site CQMP and other applicable DAIDS policies in this regard;
• Reviewing the site’s QA reports, monthly data management center (DMC) reports for site performance and lab, and external monitoring/audit reports on CRS network studies with the study Principle Investigators/ Investigators of Record;
• Ensuring that appropriate CAPAs are implemented and periodically reviewed for effectiveness and relevance;
• Identifying and responding to trends noted in workload, error rates, staff performance and all phases of the sites implementation of the CQMP;
• Completing the CQMP CRS summary QA reports for review/finalization by the CRS Leader and for submission to CTU PI and her designee, before submitting to OCSO representative for the site.
• Supervision of the CRS Quality Assurance and Quality Control functions.
• Conduct quality and compliance reviews periodically and implement initiatives to improve organizational effectiveness in quality of research.
• Develop and routinely update the Baylor Uganda Clinical Quality Management Plans
• Develop and implement standard operating procedures for external monitoring preparations and responding to findings as required.
• Conduct routine audits and checks on the quality assurance and control processes for compliance
• Review the compliance systems and structures set for research through compliance reports
• Monitor and assess the implementation of study/research protocols in line with the Clinical Quality Management Plans (CQMP).and Study sponsor requirements where stipulated.
• Develop and monitor implementation of the CQI Capacity Building Program (Training, Mentorship, Coaching and Support Supervision) based on identified needs
• Develop and maintain strategic partnerships and networks with key stakeholders, and implementing partners for management of quality research activities.
• Support the organization’s resource mobilization efforts by participating in the development and writing of grant proposals to be submitted to funding agencies.
• Develop study monitoring reports, provide feedback to study teams on monitoring findings and support the teams in developing and implementing corrective action measures.
• Make periodic assessments of frequent and critical errors across all studies and provide feedback across the department.
Required Qualification, Experience and Competencies:
• A Medical Doctor with Master’s Degree in Public Health, Epidemiology/Biostatistics, Health Services Research. Additional training in Quality Management, QI, Monitoring and/or Auditing Clinical Trials would be of advantage.
• At least 6 years as a Clinical Research Quality Manager or Trial Manager or Clinical Research Site Coordinator
• 6 Years Relevant Experience
NOTE:
Applications should include a cover letter, CV, daytime telephone contact, three traceable professional references and certified UNEB certificates as well as certified University Transcripts
You must have at least a credit 6 in MATHEMATICS and ENGLISH at Ordinary Level (UCE). Only shortlisted candidates will be contacted for interview. Please note only shortlisted candidates will be contacted.
Work Hours: 8
Experience in Months: 72
Level of Education: Postgraduate Degree
Job application procedure
Interested?
We look forward to hearing from you! Please apply directly using the link below. In case you have any further questions about the role, contact us on careers@baylor-uganda.org
https://careers.baylor-uganda.org/jobs/325
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