Clinical Quality and Training Manager (CQTM)
- valid for 15 daysuntil: 12 Jun 2022
- contract of employment
- specialist (Mid / Regular)
- full office work
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 the issues and providing guidance to the clinical team, create an environment (indirectly) 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)
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
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
Adopt innovative approaches in planning and conduct state-of -art trainings to all stakeholders involved in the clinical trial conduct process
Qualifications: In order to be considered, you need to hold academic Degree, Min. Bachelor’s degree preferably in Life Science or other similar disciplines. Fluent English verbal and writing skills and valid driving licence are required.
To be successful in this role, we expect you to have:
A min. 5 years of relevant experience in clinical operations/clinical trials monitoring & execution in pharmaceutical industry or Clinical Research Organization
Excellent knowledge of GCP and current European Clinical Trials Regulations with good knowledge of quality systems for clinical trials
Experience working in RBQM framework and proven success in improving culture of quality in line with ICH E8 (R1)
Experience using risk-based analytics to identify and manage risk and issue signals
Experience or knowledge or certification of Six Sigma or Lean processes will be an asset
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. You need excellent communication and negotiation skills, as well as proven decision-making and problem-solving capabilities. In this role, 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.
What we offer
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 40,000 employees. Together, we go further. Together, we’re life changing.
CDC Poland is part of Region South East Europe, Middle East and Africa (SEEMEA) and is a new set-up of clinical organization in Novo Nordisk Poland, covering a group of 16 countries including Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, North Macedonia, Italy, Romania, Serbia, Slovakia, Slovenia and Poland. CDC Poland is responsible for conducting clinical trials across this group of countries, providing clinical trial management and administration support to adjacent Affiliates. CDC Poland is currently responsible for approximately 20% of global patients in Novo Nordisk clinical trials.