Senior Manager, Clinical Program Quality

2 weeks ago

Cape Town, Western Cape, South Africa IAVI Full time

Position Description

Title:
Senior Manager, Clinical Program Quality

Location:
Kenya, South Africa, or Netherlands

Reports to:
Director, Clinical Program Quality

  • IAVI is seeking an experienced Senior Manager, Clinical Program Quality who will manage and drive compliance of Clinical Development operations according to current regulations and IAVI systems. The Senior Manager, Clinical Program Quality is a GCP Expert familiar with clinical trial regulatory requirements, is attentive to detail, has strong project management skills, and is versed in training and supporting clinical teams, driving successful compliance management of Clinical Development operations._

Key Responsibilities:

  • Implement and manage the Clinical Development (CD) Quality Plan to ensure that defined annual quality goals on systems, training, and risk management are met.
  • Identify vendors and sites that need to be audited including operational support for audit preparation and followup.
  • Develop and execute CD staff training on governance and procedures, regulatory requirements, and quality management systems.
  • Participate in crossfunctional teams to support continuous improvement opportunities for the development, implementation, and maintenance of CD quality systems.
  • Develop governance and procedures; manage the development of the process workflow; translating the workflow in a procedure; review and followup on team comments.
  • Support the selection process of new systems including followup on specification needs; help IT with the execution of programming and validation of new systems.
  • Manage system improvement needs; write change requests and followup on the implementation of the change request with IT.
  • Set up internal quality control plan and execute plan for established procedures within the organization on training, document management, deviation management, risk management, vendor management etc.
  • Manage deviation reporting compliance in quality management system ; ensure CD staff has the knowledge on how to enter a deviation in the system including how to write an investigation and corrective and preventive action plans; check deviation trends that need further investigation and followup.
  • Develop tools and reports to visualize quality compliance such as: document management compliance reports for the trial master file and controlled document systems; training management compliance report for the learning management system; quality metrics and reports for the clinical trial database.
  • Manage and integrate new guidelines in current CD procedures and systems to ensure compliance with current applicable requestions.
  • Collect metrics for Quality Management Council meetings, and present on other related topics such as the updated CD quality plan and new CD quality initiatives.

Education and Work Experience:

  • Bachelor's degree in a scientific or related field is required; an advanced degree is highly desirable.
  • Minimum 8 years relevant experience in clinical trial operations, including 4 years in clinical trial management or equivalent experience at study sponsor or CRO is required.
  • Experience working with quality and document management systems workflows and operations is required.

Qualifications and Skills:

  • Expert knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR and other relevant regulations is required.
  • Ability to resolve complex quality issues using good judgment within defined procedures and policies and applicable guidelines to determine corrective and preventive actions is required.
  • Strong organizational skills and ability to work collaboratively and effectively in large, complex, multidepartmental, crossfunctional teams is required.
  • Technical skills to assess systems support needs, adherence and improvement of systems are required.
  • Excellent oral and written communication skills are required. This includes ability to conduct presentations of technical information concerning specific quality related projects and systems.
  • Excellent attention to detail is required
  • Ability to work independently on complex tasks is required.
  • Technical knowledge and understanding of electronic document, quality and learning management systems is required.
  • Excellent computer skills with software tools needed to fulfill the responsibilities of position is required, including Microsoft Excel, PowerPoint, and Word, and LucidChart or similar software.
  • Experience working in remote, virtual, and/or global teams is highly desirable.

Organizational Overview:

About ADVANCE:


ADVANCE (Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic) is a ten-year cooperative agreement with the U.S.

Agency for International Development (USAID), through the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). This visionary $200 million program will run until June 2026 and is part of IAVI's 22-year co

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