Clinical Quality Training Manager

1 month ago

Johannesburg, South Africa Novo Nordisk AS Full time

Are you passionate about clinical quality and training? Do you want to be part of a team that brings new treatments to patients faster and smarter? We are looking for a Clinical Quality Training Manager to join our SEMEEA Clinical Development Centre (CDC) leadership team. If you are ready for an exciting journey into new therapeutic areas and ways of working, apply now and join us at Novo Nordisk.

The role is based in Johannesburg, South Africa and will be reporting to the Clinical Operations Excellence Head.

The position

As a Clinical Quality Training Manager, you will play a crucial role in ensuring high-quality clinical trials and training within the CDC. In addition, you will be responsible for cascading down the global quality focus targets and areas to the CDC level, managing the risk, escalating issues and providing guidance to the clinical team, creating an environment in the CDC to achieve the quality objectives and cross-collaboration within the CDC and between Affiliates, Regional and Global teams.

Your Main Responsibilities will be:

Developing and executing the CDC clinical quality and training plan based on quality management review results and identified issues Conducting site quality visits and process checks to maintain high quality in the CDC Identifying and addressing issues through data and trend analysis, and escalating them if necessary Acting as a GCP and SOP expert within the CDC and providing clarifications to stakeholders Coordinating and delivering training to ensure all stakeholders involved in the clinical trial conduct process are well-trained

Qualifications

As a Clinical Quality Training Manager, you need to have an academic Bachelor’s degree or higher, preferably in the discipline of Life Sciences, Medicine, or Pharmacy. Moreover, you need to have a Minimum of 5 years of experience in clinical operations and clinical quality and training in the Pharmaceutical or Healthcare industry. Nevertheless, you need to have proficiency in both oral and written English and a valid driving license.

To be successful in this role:

Previous experience in GCP audits and authority inspections is preferred Experience in coordinating and delivering training and ability to work in virtual multi-cultural teams Advanced knowledge of the International Conference on Harmonization Good Clinical Practice (ICH GCP) Excellent organizational, prioritization, and project management skills Analytical mind, patience, and ability to lead without authority Excellent communication, negotiation, decision-making, and problem-solving skills Ability to manage multiple priorities and adjust quickly to new situations

We are looking for someone who enjoys travels as the job involves traveling - both domestic and international.

About the department

The SEMEEA Clinical Development Centre (CDC) is located in Johannesburg, South Africa. As part of our CDC leadership team, you will be at the forefront of driving clinical quality and training in our exciting journey into new therapeutic areas. The CDC is a dynamic and collaborative environment, where cross-collaboration within the CDC and between Adj. Affiliates/Regional/Global teams are highly valued.

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