Clinical Quality

6 days ago

Johannesburg, South Africa Novo Nordisk Full time

Would you like to be part of our Clinical Development Center South Africa (CDC-ZA) management 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 & Training Manager, you will be responsible for cascading down the global quality focuses targets/areas to the CDC level, managing risks, escalating issues and providing guidance to the clinical team, and creating an environment in the CDC to achieve the quality objectives and cross-collaboration within the CDC and between the Affiliate, Regional, and Global teams.

Your Main Responsibilities:

- Prepare and execute the CDC clinical quality and training plan based on Quality Management Review 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 state-of-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 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, preferably in the discipline of Life Sciences, Medicine or Pharmacy. Proficiency in both oral and written English (ability to produce clear and non-ambiguous documents) and valid driving licence are required.

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

- Minimum of 5 years of experience within clinical operations including 2+ years of experience in a relevant role: you must have worked with quality management plans and CAPAs, taken part in inspections/audits, performed oversight visits, provided trainings
- Previous experience of system audit (CTMS, etc.) is preferred
- Attention to details and ability to identify opportunities for improvement
- Assertiveness while staying patient, stress-resistant and demonstrating calm demeanor
- Excellent communication and negotiation skills, as well as proven decision-making, conflict management and problem-solving capabilities

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

**About the Department**

Working with the clinical trial team in South Africa and collaborating across SEEMEA and International Operations, you will join an expanding dedicated local team of Clinical professionals on a mission to create better treatments and care for patients with Diabetes, Obesity, Rare Disease and the new therapeutic areas (Cardiovascular Diseases, Alzheimer’s Disease, NASH, Sickle Cell Disease) that Novo Nordisk is investing in.

You will be reporting directly to the CDC-ZA Director - together with another Clinical Quality & Training Manager and a few Clinical Research Managers. Your wider team also includes CTAs, CRAs, Trial Managers, and a Start Up group.

**Working at Novo Nordisk**

Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing.

**Contact**

**Deadline**

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 th

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