Cdc Trial Manager - Madrid, España - Novo Nordisk

Novo Nordisk

Empresa verificada

Madrid, España

hace 3 semanas

Publicado por:

Isabel García

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Descripción

CDC Trial Manager

Category:

Clinical Development
Location:Madrid, Comunidad de Madrid, ES- Are you passionate about Trial Management and would like to be part of the patient's life change?- Do you want to be part of our Clinical Development Centre (CDC) team integrated by Spain and Portugal? We are currently recruiting 2 Clinical Trial Manager for our Cardiovascular and RareD teams.- Our office is in Madrid, but position could be based in anywhere in Spain.

The Position

As a Clinical Trial Manager working in the Cardiovascular Disease (CVD) or in Rare Diseases (RareD) team, you will use your project management skills to drive clinical trials in the CDC forward, making sure they are in accordance with the protocol, company policies, Standard Operating Procedures (SOPs), countries' legislation and ICH GCP requirements. You will be responsible for all the aspects of the clinical trials within the CDC project team of CRAs and CTAs, including strategy, country budget, recruitment, retention, risk analysis and management, database lock (DBL) and archiving.
Your responsibilities will include:
Project planning, management, and execution of assigned clinical trials in the CDC and adjacent affiliates in accordance with applicable regulatory requirements, NN Protocols and SOP's. Coordinating the CDC trial teams at a project level within the 2 countries.
To lead the project team, taking accountability for the trial budget, ensuring successful startup clinical activities, setting project specific strategies and providing direction to ensure successful project delivery. Leading the planning, execution and communicating between relevant roles, such as CDC, Clinical Trial Assistants and Clinical Research Associates (CRA), as well as CRA coaching.
To ensure effective communication of all trial related issues between the headquarters, CDC, other affiliates, and other internal/external stakeholders. To act as project manager for the trial management activities in the CDC from site selection to postclinical trial activities.
Representing CDC countries in study meetings as relevant: Country Calls, Monitor and Investigator meetings, Study Result meetings.
Proactive risk identification and mitigation plans in the CDC level and adjacent affiliates.
We are looking for a passionate and proactive solutionorientated professional able to coordinate tasks, identify potential risks as well as mitigations, effectively communicate between the Trial Squads, the Monitors (CRAs) and the Heads of Clinical/Clinical Research Managers to facilitate progress and global coordination of the clinical trial programme.
Qualifications
Minimum Bachelor's degree level in Life Sciences or equivalent
Strong experience in Clinical Research, including at least 2 years in a Trial Management role. Experience with international clinical trials is desired for this position
Strategic and analytical mindset. Critical thinking, risk analysis, project management
Ability to work in changing environment, leading an agile methodology, being innovative and finding efficient ways of doing things.
English fluency is required for this role, alongside with Spanish. Portuguese would be a plus
About the Department
You will be part of a broader unit named CDC (Clinical Development Center) that covers Spain and Portugal. As part of this team, you will get to collaborate with a wide range of colleagues such as CRAs, Trial Managers, CTAs, Feasibility Managers and other crossfunctional departments. The one thing that keeps the Clinical Operations team marching to the same beat is its patientcentered focus. As patients' needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. With this ambition, we are currently immersed in a transformational journey lead by the management team in which the new CRM will land.
Working at Novo Nordisk
We are a proud lifescience company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things from the building blocks of life that form the basis of groundbreaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we're all here to ensure that people can lead a life independent of chronic disease.
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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