Vacant job

Lihme Research & Healthcare is a small, dedicated company that works closely with researchers and clinicians in academic clinical research. We are growing alongside our collaborations and assignments, and as more choose to work with us, we now need to welcome another colleague to our team. We are looking for someone with experience in clinical studies who feels confident in ICH-GCP. Whether you currently work as a CRA, clinical project manager, study coordinator, or in a combined role, we are curious about you, your experience, and what you want to contribute to us.

With us, you will work closely with researchers, investigators, and clinicians, primarily in academically initiated research. You will become a key person in the planning, execution, and follow-up of studies within pharmaceuticals, medical technology, and registry research in academic research environments.

In this role, you will have a broad and varied responsibility within clinical research. You will lead and follow up studies from start to finish and work closely with researchers, investigators, and clinical teams. The work includes project management of various types of studies and other healthcare-related projects as well as monitoring clinical trials.

You will plan and drive studies forward by following up timelines, budgets, and deliverables while ensuring that all activities are conducted according to ICH-GCP, ISO 14155, and other relevant regulations. The role involves producing and quality assuring study documentation, protocols, and risk management plans, as well as collaborating with R&D units and regulatory functions to create effective working methods.

As a monitor, you will be responsible for planning and conducting initiation and monitoring visits, ensuring protocol compliance and data quality, conducting source data verification, and managing queries. You will support sites in their daily study work and contribute to smooth processes and high patient safety.

You will also play a central role in developing and further developing Lihme's internal working methods and routines for clinical studies, where your experience and judgment contribute to quality, structure, and long-term development.

We believe that you recognize yourself in several of the following points – you do not need to meet all of them to thrive with us.

• Experience in driving and coordinating academic clinical studies
• Experience in monitoring clinical trials
• Very good knowledge of ICH-GCP and/or ISO 14155
• Experience in developing, working with, and improving SOPs
• Experience in medical technology trials and performance studies
• Work with quality registers and research databases
• An independent, structured, and solution-oriented working style
• Good communication skills and a professional approach
• Very good ability to express yourself in Swedish and English, both orally and in writing

We offer

• A small, personal, and research-oriented company where we value collaboration, open dialogue, and humility. Varied projects within pharmaceuticals, medtech, registries, and academic research
• Short decision-making paths and significant personal responsibility
• Opportunity to influence and develop Lihme's internal routines and working methods for clinical studies.
• Location in Uppsala, the work involves travel during periods

Does this sound like something for you, or do you want to know more before applying? You are warmly welcome to contact us.