Team Lead – Clinical Safety and Reporting

Job title:

Team Lead – Clinical Safety and Reporting

Company:

Cook Group

Job description

Overview:Would you like to take on a key role where you put your expertise in local and global regulatory requirements and standards as well as adverse events in clinical studies into play?As Team Lead, you will be responsible for the day-to-day management and coordination of our team of three Clinical Review Nurses in Europe. The team is part of our global Clinical Affairs function. We are 21 employees in Europe and 118 in total globally, responsible for designing, conducting, and reporting on clinical trials.On a day-to-day basis, you will work closely with both the clinical study teams as well as global and local colleagues. Collaboration between functions and departments is key for us giving us the benefit of bringing various specialist skills.Welcome to Cook Medical – we make a difference every dayCook Medical develops and produces medical devices within many clinical specialties that are manufactured in specific countries and locations for global distribution.Responsible, competent, and professional employees are our most valuable resource, and they are at the core of our philosophy of developing innovative medical solutions to raise the quality of patient treatment worldwide. Responsibilities:Help set the direction for our monitoring and reporting of adverse events in clinical studiesYou will be responsible for monitoring adverse events that occur in connection with clinical studies on our products, as well as reporting of the events to relevant authorities and global Cook Medical manufacturers.In addition, you will be involved in:

• Further developing and streamlining global processes and standards in collaboration with other teams and colleagues on a global scale.
• Ensuring that the targets for reporting adverse events are met as well as providing status reports to global clinical management.
• Coordination of priorities, tasks and activities within monitoring and reporting of adverse events in connection with clinical studies.
• Assessment of the need for resources in connection with monitoring and reporting of adverse events in clinical studies.

Qualifications:Clinical profile with experience that can challenge the status quoYou are engaged and can drive change, just as you are a skilled communicator. In addition, you are always open to input and adapt your communication in relation to cultural differences and understand organizational structures.In addition, we expect that you:

• Are a trained nurse or have a similar relevant scientific education – preferably with experience from the medical or pharmaceutical industry
• Have extensive practical experience as a nurse
• Have solid experience from a similar role, where you have e.g. reported side effects to a manufacturer or have sat as a clinical project manager or in a CRA role
• Have knowledge of good clinical practice, and it is an advantage that you have experience with global legislation within clinical trials.
• That you speak and write both Danish and English fluently – English is our corporate language.

Cook as a workplaceCook Medical is a family-owned American company with approximately 11,000 employees worldwide, working every day to develop and manufacture medical devices for minimally invasive surgery, thereby promoting quality of life and life-saving treatment. In Denmark, we are around 750 colleagues based in Bjæverskov and Ringsted who contribute to this.At Cook Medical, we are proud of our very special “Cook spirit”. No matter where you go in the organization, you will be greeted by kindness and pride in the quality of the work we do and the products we create. As a Cook employee, you’ll help develop innovative medical solutions – and we know that we make a difference for people around the world every day.We value qualities such as determination, loyalty and humour and work for an open dialogue. As a new Cook colleague, you will undergo a well-planned, internal training course, so you quickly gain in-depth knowledge of the company, the products and your colleagues. In addition to a salary package with bonus and pension, we offer a high degree of flexibility in the planning of your work with the task in focus, equipment for working from home, a good canteen arrangement when you are on site, health insurance and activities such as Art Association and Sports Association and free use of the company’s own gym.Are you interested?If you recognize yourself in the role, send us your CV with a brief motivation for applying for the job via the link below – preferably as soon as possible, and no later than January 12th, 2025. We hold interviews on an ongoing basis.If you have any questions about the job, you are welcome to contact Maja Skytte Jensen, Director, Post Market, Clinical on +45 41 95 42 22.You can read more about Cook Medical onWe look forward to hearing from you!

Expected salary

Location

Bjæverskov, Sjælland

Job date

Sun, 15 Dec 2024 06:19:01 GMT

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