Research Assistant for evaluating ‘sufficient clinical evidence’ in current regulatory practice of Medical Devices

The Department of Clinical Medicine, Faculty of Health Sciences at Aarhus University call applications for a position as a Research Assistant starting on the 1 January 2027 or as soon as possible thereafter. The position is a 3-months full-time position with possibility to continue as a fully financed PhD fellowship.

Department of Clinical Medicine

The Department of Clinical Epidemiology is a research department at Aarhus University Hospital, within the Department of Clinical Medicine at Aarhus University. Researchers in the department use advanced epidemiological methods to study different topics related to health research, including patient and medical device safety research. Furthermore, the department is involved in counselling health care professionals to improve the quality of health care, treatment, and research. Projects are carried out in cooperation with Danish and international collaborators. The department has overall responsibility for the Master's degree programs in medicine and in molecular medicine. You can read more about the department here and about the faculty here.

As a Research Assistant, you will be part of a research group for surgical patient safety at the Department of Clinical Epidemiology, which uses national registries together with systematic review methodology to evaluate prognosis of patients undergoing major orthopedic surgical procedures.

Project description

Innovative medical devices within orthopaedic hip and knee surgery can offer important benefits to patients, especially when existing diagnostic or treatment options are limited. At the same time, the available clinical evidence may be limited or contain uncertainties when a device is assessed for market access. Regulators therefore need to decide when evidence is sufficient, what uncertainties can be considered acceptable, and under what conditions additional evidence should be collected after a device enters the market.

In this position and the potential following PhD project, you will evaluate what is considered “sufficient clinical evidence” in current regulatory practice, balancing methodological rigor of clinical studies and post-market clinical follow-up obligations.

Specific project aims and methods are:

• Identification of current definitions, thresholds, and interpretation of sufficient clinical evidence in regulatory documents (Systematic review of existing regulatory documentation)
• Identifying definitions and interpretation of sufficient clinical evidence by regulatory assessors (interviews with Notify Bodies assessors, Expert Panel members, regulators, and patient representatives)
• Addressing the challenge of medical device variants (Systematic review of peer-review published clinical and post-marketing studies on medical devices variants and registry-based study to compare the performance and safety of these variants)

This project is part of the European COMPASS4MD consortium and will involve close collaboration with research institutes, regulators, clinical experts, patient representatives, and other partners across Europe. You should be comfortable working independently on your own research while also communicating easily and contributing to shared activities, meetings, workshops, and deliverables with European project partners. Some travel within Europe may be part of the position. We do not expect candidates to already possess expertise in all project’s areas; we particularly value the ability and motivation to work across disciplinary boundaries.

Your job responsibilities

As a Research Assistant, your main tasks will consist of:

• Manage, carry through and conclude on your research projects
• Actively participate in PhD courses
• Write scientific articles and finalize your PhD thesis
• Participate in international meetings
• Conduct a research stay at an institution abroad
• Teach and disseminate your research

In addition to the main supervisor Professor Alma B. Pedersen, you report to Professor and Chair of the Department of Clinical Epidemiology Henrik Toft Sørensen.

Your competences

• Master’s degree in a relevant field, such as Medicine, Epidemiology, Health science, Biomedical Engineering or a related field. As the project combines the analysis of clinical evidence with empirical research into regulatory decision-making, we particularly welcome candidates who can connect biomedical or clinical questions with policy, governance, and stakeholder perspectives.
• An interest in systematic review methods, epidemiology, and medical devices safety.
• Good communication, collaboration and organizational skills, good interpersonal skills, and willing to contribute to a positive working environment.
• Research experience and writing skills demonstrated through a thesis, publications, or previous research projects.
• Excellent command of English is required.

Shortlisting will be used.

Formal requirements

The position is initially available as a Research Assistant for a 3-months period. The potential enrolment as a Ph.D. student for an additional 3 years will be agreed upon between the candidate and the main supervisor Alma B. Pedersen. Additionally, note that it is a prerequisite that the Ph.D. candidate is enrolled as a Ph.D. student at Aarhus University Graduate School of Health in a separate procedure before starting as a Ph.D. student. The successful candidate will work on that together with the main supervisor.

Questions about the position

If you have any questions about the position, please contact Professor Alma B. Pedersen at e-mail: [email protected].

Your place of work will be the Department of Clinical Epidemiology, Olof Palmes Allé 43-45, DK-8200 Aarhus N, Denmark.

Relevant candidates will be called for job interviews 9-13 November and 16-20 November, preferably physically in Aarhus although online is also an option.

Terms of employment

• Appointment as a research assistant requires academic qualifications at master's degree level.
• Further information on the appointment procedure can be found in the Ministerial Order on the Appointment of Academic Staff at Universities.
• The appointment is in accordance with the Danish Confederation of Professional Associations (Akademikerne).
• Remuneration is in accordance with the above, and the Salary agreement catalogue for staff at Health.
• Further information on qualification requirements and job description can be found in the Ministerial Order on Job Structure for Academic Staff at Universities.

Application

Your application must include the following:

• Motivated application
• Curriculum Vitae
• Diploma
• Template for applicant - other academic positions
• A list of publications can be uploaded if relevant for the position
• A teaching portfolio can be uploaded if relevant for the position. We refer to Guideline on the use of teaching portfolios
• References/recommendations can be uploaded separately in the recruitment system

We refer to the faculty’s Guidelines for applicants.

Aarhus University’s ambition is to be an attractive and inspiring workplace for all and to foster a culture in which each individual has opportunities to thrive, achieve and develop. We view equality and diversity as assets, and we welcome all applicants.

The application must be submitted via Aarhus University’s recruitment system, which can be accessed under the job advertisement on Aarhus University's website.