Novo Nordisk
Location
Madrid | Spain
Job description
Are you passionate about Quality within Clinical Trials?
Do you want to be part of our Clinical Development Centre (CDC) team, integrated by Spain and Portugal? Do you identify yourself with a role of influence and communication?
Are you excited by the possibility to streamline the strategic integration of the function of quality and training as key success factors for a good execution of clinical trials?
If your answers are ‘yes’, don’t hesitate and apply now to this unique opportunity!
The position would be based in Madrid, but the scope will be the whole Clinical Development Centre.
The position
As our Clinical Quality & Training Manager (CQTM), you will have a key role as part of the Clinical Operations Excellence team in collaboration with Innovation Manager and other members of the Team in the CDC Spain. Your main contribution will be bringing quality and training to teams mobilizing towards a quality and responsibility mindset through your communication and influence.
Among your responsibilities:
To ensure compliance with procedures, legislation and good clinical practice, supporting the realisation of results in a more efficient way
You will be pivot to the cultural transformation towards agile ways of working already ongoing and new ones coming in
We expect from you to be an active member of the Clinical Operations Excellence and Start Up Unit (COE & SSU) Team within the CDC. You will streamline the strategic integration of the function of quality and training as key success factors for a good execution of clinical trials.
To support Clinical Quality & Training Manager and Therapy Area Heads by maintaining appropriate and consistent training records across CDC.
To continuously monitor and evaluate the training program to identify the areas for improvement
To analyse the root cause data collected (from audits, PDs, serious breaches) to identify areas where the stakeholders lack knowledge, skills or abilities that could have prevented the incidents from occurring, and deliver timely training to achieve the right level of compliance in trial conduct.
To identify potential risks and non compliance and to develop and introduce preventing actions to support the quality.
To stablish close collaboration with CDC super users and clinical systems implementation managers to understand the future process requirements and plan and conduct the periodic compliance checks.
To be in close contact with similar roles at Region, Headquarters and other countries with the aim of building a network at all relevant levels.
Maintaining current knowledge of Clinical systems as of therapeutic areas, SOPs, relevant legislation and ICH GCP guidelines
Qualifications
Knowledge of industry standards abs regulations related to Clinical Trial Quality management, including GCPs guidelines.
In depth experience in clinical operations processes and end to end clinical trial conduct.
Ability to analyse quality metrics and identify trends and areas of improvement.
Quality, analytical and Risk-based mindset
Project management skills, strategic thinking approach. Excellent communication and presentation skills. Cross-functional mindset and team player, used to working internationally
Ability to manage complexity when solving problem that do not have a clear solution
Independence, attention to detail and initiative is expected when analysing planning and performing tasks either assigned by management or initiated by the individual. Flexibility and ability to prioritise is necessary to manage tasks from different stakeholders
The CQTM Specialist is expected to travel to deliver training in-person at regional meetings, for 1:1 training of new-starters, and to support department in-person training. In addition, it is expected that online / on-demand and live remote (Teams) based training is used to support activities
Ability to build and maintain strong working relationship with interna and external stakeholders to deliver results.
Fluent in English is a must.
About the Department
You will be part of this international team, integrated by people in Spain, and Portugal.
You will report to the Head of Clinical Operations Excellence and Start Up Unit Team in CDC Spain and will be in close collaboration with all Therapy Area heads working cross-functionally in a very dynamic environment.
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.
Contact
If you believe you are qualified and are willing to take the challenge, please submit your updated CV in our platform.
Deadline
Please apply before March 12th
Job tags
Salary
