Senior Clinical Research Associate

3 weeks ago

Malmö, Sweden Coloplast Full time

If you're passionate about driving impactful research and contributing to the advancement of Medtech innovations, we might have the role for you. We are currently looking for a Senior Clinical Research Associate to join our global Medical & Scientific Affairs team. You will be reporting to our Clinical Research Manager and drive assigned clinical studies from start to end.

About the job

This role offers a unique opportunity to engage in the full spectrum of clinical studies, from project inception and planning, study monitoring and reporting of study findings. Moreover, your role extends beyond research, as you'll partner with our commercial teams to translate key findings into impactful messaging for a wide range of audience. You'll immerse yourself in every aspect of the process, contributing to both short-term objectives and long-term strategic goals.

Key Responsibilities:

Independently develop clinical investigation documents, such protocols, case report forms, and patient information for clinical studies. Manage and coordinate ethical and competent authority submissions and approvals. Communication with investigators and internal stakeholders Monitor clinical studies to ensure adherence to protocols and patient safety, primarily in-house Analyze study data and compile comprehensive reports on study outcomes. Collaborate closely with commercial teams to integrate study findings into promotional materials Assess and validate the quality and accuracy of marketing and market access materials content based on available clinical studies and publications. Provide support to junior team members and students

About you

We are looking for someone with previous experience and in-depth knowledge of clinical investigation processes, including protocol development, monitoring, ethical review submission, and reporting of study data. You are either currently working as a CRA or have worked with clinical studies in an academic setting, and are now looking for the opportunity to independently drive assigned studies with medical devices from start to end.

PhD or master’s degree in Life Science, Natural Science, or Medicine. Minimum of 3 years' experience in clinical studies, preferably within the MedTech industry, and working in accordance with ISO-14155 and MRD Experience with ethical and competent authority submissions Proficiency in English and familiarity with Microsoft Office suite. Experience with study management tools such as eTMFs and EDCs is highly desirable.

Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox, Provox Life and Tracoe.

We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business.

Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.

Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S

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