Senior CDC Trial Manager

3 tygodni temu

Warsaw, Polska Novo Nordisk AS Pełny etat

You are applying to be a part of a Novo Nordisk Talent Pool (Pipeline), not a currently open position. Joining our pipeline means that you will be considered as a potential match for current and upcoming positions to ensure you don’t miss out on a life-changing career. When an opportunity arises, we will reach out and invite you for an interview. We will keep your application for six months ensuring the best opportunities to provide a solid match for open positions. If you would like to be considered for a Trial Manager or similar roles in future, please submit your CV. We are looking forward to receiving your application

Are you an expert in project management of clinical trials? Would you like to use your experience to continuously optimize the way trials are conducted? Do you want to give patients a better clinical trial experience? If yes, then you could be the Senior Trial Manager in our Clinical Development Centre (CDC)

The position will be based in Warsaw, Poland

The position

In the role of CDC Senior Trial Manager you will be focusing on developing and executing all stages of the allocated Trial Strategic Plan on the CDC level. On a daily basis, you will manage allocated trials on CDC level to deliver the trials KPIs. You will also manage the CDC Trial Teams, establish and maintain professional relationships with internal and external stakeholders, and carry out other additional responsibilities defined by your line manager.

Your responsibilities will include:

Developing and executing CDC level Trial Strategic Plans and, if necessary, Risk Management Plans, for all trials under your responsibility. As well as driving patient relocation in close collaboration with adjacent affiliates.

Organizing kick-off meetings with CDC Trial Team members (Start-up CRAs, CRAs, and CTAs) and later following up on their progress and if necessary escalating identified issues/challenges to appropriate stakeholders.

Performing TM monitoring, as well as, creating and reviewing trial country and CDC budgets and approving trial related payments.

Supporting CRAs by performing co-visits, organizing pre-audit meetings, reviewing and approving all types of site visit reports, approving GL forms, performing IMPACT quality checks etc.

Building and maintaining relationships within the CDC Trial Team and the Trial Squad. And acting as a leader for all CDC Trial Team members in regards to trials under your responsibility.

Qualifications

You need to present excellent communication and presentation skills alongside the ability to build relationships with various stakeholders. What is more, you need to possess negotiation as well as influencing skills.

We expect you to have:

Master’s degree in Life science or similar Fluency in English – written and spoken Minimum 3 years of experience in operational aspects of planning and conducting clinical trials. Previous CRA experience will be preferred. Minimum 2 years of experience in independent project management of clinical trials (multi-country experience is an advantage but not mandatory)  Proactivity - initiating new ideas and taking actions to improve the existing ways of working Ability to work in changing environment, to be agile and proactively find efficient ways of doing things Ability to impact & influence others to achieve shared goals without using formal power

On a personal level, you need to be team oriented with a high degree of flexibility and cross-cultural awareness, as you will be interacting with affiliates from several different countries. You need to be excellent in foreseeing difficulties and taking preventive actions as well as assessing problems as they arise and making quick decisions on appropriate actions.

About the department

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. 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.

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