Clinical Quality and Training Manager

2 weeks ago

Johannesburg, Gauteng, South Africa Novo Nordisk Full time
Would you like to be part of our SEMEEA Clinical Development Centre leadership team as we set out on a journey into new and exciting therapeutic areas and ways of working?

Can you help us bring new treatments to patients, faster and smarter by leading and optimizing clinical quality and training? Then you could be our new Clinical Quality & Training Manager in Johannesburg, South Africa

The position


As a Clinical Quality and Training Manager, you will be responsible for cascading down the global quality focuses targets/areas to the CDC level, managing the risk, escalating issues and providing guidance to the clinical team, create an environment in the CDC to achieve the quality objectives and cross-collaboration within the CDC and between Adj.

Affiliates/Regional/Global teams.

Your Main Responsibilities:

  • Prepare and execute the CDC clinical quality and training plan based on QMR results and issues identified in previous year(s) and give quality input to the CDC strategy based on upcoming clinical trial activities and quality management review
  • Conduct site quality visits and process checks on an ongoing basis to review and maintain high quality in CDC, manage and support activities during the preparation, duration and follow up of audits and inspections
  • Identify issues based on data and trend analysis, inform the appropriate stakeholders about them, impose the solutions, check the implementation of the solution, escalate the issues to higher level management, if necessary
  • Act as a GCP and SOP expert within CDC and provide clarifications to all questions raised and adopt innovative approaches in planning and conduct stateof art trainings to all stakeholders involved in the clinical trial conduct process
  • Local training point of contact. In close collaboration with local affiliate identifies, supports and coordinates local training needs, ensures new hires (CRAs) are trained as required and on time; coordinate and/or conduct system and process trainings within the CDC, as needed.

Qualifications


In order to be considered, you need to hold academic Bachelor's degree or higher is essential, preferably in the discipline of Life Sciences, Medicine or Pharmacy.

Proficiency in both oral and written English and valid driving licence are required.

To be successful in this role, we expect you to have:

  • Minimum of 5 years of experience within clinical operations and/or clinical quality and training area, gained in the Pharmaceutical / Healthcare industry.
  • Previous experience of GCP audits and authority inspections is preferred.
  • Previous experience in coordinating and delivering training required
  • Must be able to work in virtual multicultural teams
  • Advanced ICH GCP knowledge
  • Ability to interact with all levels of clinical research management and influence to achieve results
  • Excellent organisational, prioritization and project management skills
  • On a personal level, you should have analytical mind, be patient, have the ability to lead without authority and have high focus on quality and patients' safety.
  • Excellent communication and negotiation skills, as well as proven decisionmaking and problemsolving capabilities.
  • Ability to manage multiple priorities is crucial, as well as willingness to adjust quickly to new situations in a continuously developing environment.
  • Experience in project and site management is strongly desirable.
We are looking for someone who enjoys travels as job involves traveling - both domestic and international.

Working at Novo Nordisk
At Novo Nordisk, we don't wait for change. We drive it.

We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.

We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them.

From research and development, through to manufacturing, marketing and sales - we're all working to move the needle on patient care.


Contact

Deadline
March 24th 2023

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.


At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.

We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.

We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.

Together, we're life changing.

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