Arbetsbeskrivning

Job description

If you are 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 the global Medical & Scientific Affairs team at our Client company, for a temporary maternity cover. Our client is a a global medical device leader dedicated to significantly improving the patients' quality of life, by delivering class II and III medical devices.

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 will immerse yourself in every aspect of the process, contributing to both short-term objectives and long-term strategic goals.

This is a consulting assignment within Randstad Life Sciences which is specializing in competences within Life Science. As a consultant with us, you get a competitive salary, benefits and collective agreements. Your consultant manager is always there for you and ensures that you get varying and developing assignments at different companies, within different industries. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

If you are ready to make a difference and join our customer exciting growth journey, apply before the 30th of December 2025. Selection and interviews will be ongoing. The starting date will be agreed upon by all parties.

Responsibilities

• Oversee and manage development of clinical investigation documents
• Manage and coordinate ethical and competent authority submissions and approvals.
• Communication with investigators and internal stakeholders.
• Oversee analysis study data and compile comprehensive reports on study outcomes.
• Collaborate closely with commercial teams to integrate study findings into promotional materials
• Ensure alignment of SOPs and templates to latest regulations (ISO 14155, MDR, etc)
• Train and mentor new team members on clinical investigation processes

Qualifications

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 currently working with clinical studies of medical devices, and are now looking for the opportunity to independently drive study activities.

• PhD or Master's degree in Life Science, Natural Science, or Medicine.
• Minimum of 3 years' experience in clinical studies 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.

About the company

Randstad

At Randstad, we see the possible in people. With business all over Sweden and in all areas of expertise, we help people find work that feels good, where they get the opportunity to develop and realize their true potential.

With close to 600 000 employees in 38 countries, Randstad is the global leader in the HR services industry. Our mission is to become the world’s most valued working life partner. By combining our passion for people with the power of today’s technology, we support people and organizations in realizing their true potential. We call it Human Forward.