Clinical Quality & Training Manager at Novo Nordisk

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