Manager, Clinical Program Quality

5 maanden geleden

Amsterdam, Nederland IAVI Voltijd

**Job Title**: Manager, Clinical Program Quality
**Location**: Amsterdam, Netherlands; Cape Town, South Africa; South Africa Remote; Nairobi, Kenya; OR United Kingdom Remote
**Reports to**: Director, Clinical Program Quality

**Position Summary**:
Are you an experienced clinical quality and compliance leader who is eager to make an impact in a mission-driven organization?

IAVI is seeking an experienced Manager, Clinical Program Quality who will manage and drive compliance of Clinical Development operations according to current regulations and IAVI systems, focusing on system implementation, execution and improvement, successful conduct of IAVI clinical trials within current industry standards.

**Key Responsibilities**:

- Work with cross-functional teams to support continuous improvement opportunities for the development, implementation, and maintenance of Clinical Development (CD) quality systems such as Document Management Systems, Clinical Trial Management System (CTMS) and Learning Management Systems (LMS).
- Develop and/or update governance and procedures for CD quality systems on document management, clinical trial management, and learning management, including managing the development of the process workflow; translating the workflow into a procedure; reviewing and following-up on team comments.
- Support the selection process of new systems including follow-up on specification needs; help IT with the execution of programming, and validation of new systems.
- Manage system improvement needs; write change requests and follow-up on the implementation of change requests with IT.
- Set up internal quality control plans for IAVI systems and execute plans for established procedures within the organization on training, document management, and clinical trial management.
- Manage deviation reporting compliance in quality management system for the CD team; 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 follow-up.
- 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 reports for the learning management system, quality metrics and reports for the clinical trial management system.
- Develop metrics, dashboards, and reporting tools for risk, quality and performance management.
- Manage and integrate new guidelines, such as ICH GCP R3, in current CD procedures and systems, ensuring compliance with current applicable regulations.
- Help clinical research associates and clinical trial managers facilitate the process for measuring site performance and plan timely corrective actions.
- Set up processes to facilitate documentation of centralized monitoring activities e.g., risk/issue(s) findings, escalation, tracking and resolution, etc.
- Perform other duties assigned by the Manager as needed.

**Education and Work Experience**:

- Bachelor’s degree in a scientific or related field is required; an advanced degree is highly desirable.
- Minimum 6 years relevant experience in clinical trial operations, including 2 years in clinical trial management or equivalent experience at study sponsor or CRO is required.
- Experience working with quality management, clinical trial management, and document management systems workflows and operations including business system administration is required.

**Qualifications and Skills**:

- Experience with and knowledge of clinical research operations, Good Documentation Practices, ICH GCP, FDA CFR and other relevant regulations is required.
- Experience resolving 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, multi-departmental, cross-functional teams.
- Technical understanding of computerized document, quality, clinical trial, and learning management systems, as well as skills to assess systems support needs, setting-up systems, adherence, and improvement of systems are required.
- Excellent oral and written communication skills, including ability to conduct presentations of technical information concerning specific quality related projects and systems.
- Excellent attention to detail.
- Ability to work independently on complex tasks.
- Excellent proficiency in Microsoft Excel, PowerPoint, and Word, and LucidChart or similar software is required.
- Experience working in remote, virtual, and/or global teams is highly desirable.

**Organizational Overview**:
**IAVI CORE VALUES**:

- Dedication to the Mission: We are committed to the translation of scientific discoveries into affordable, globally accessible public health solutions.
- Innovative Evolution:

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