PhD position Remote Decentralised Clinical Trials, Trials@home (1.0 FTE)

PhD position Remote Decentralised Clinical Trials, Trials@home (1.0 FTE)

Published Deadline Location
2 Apr 8 May Utrecht

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Investigate regulatory barriers and facilitators for conducting remote decentralized clinical trials within the current European regulatory framework

Job description

The Division of Pharmacoepidemiology and Clinical Pharmacology is looking for a PhD candidate for a full-time 4-year research position.

The Division of Pharmacoepidemiology and Clinical Pharmacology is a part of the Trials@home consortium, a large (30+ partners) IMI funded private public partnership which aims to explore the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Remote Decentralised Clinical Trials (RDCTs) make use of new (digital) innovations and enable participants to participate in clinical trials more easily. The benefits of this approach include, amongst others, less frequent visits to a clinical trial centre, if at all. One of the key-focuses of the Trials@home project is to assess the regulatory, ethical and legal aspects of the current EU environment relevant to RDCTs. 

As a PhD you will be employed in the Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences of the Faculty of Science, Utrecht University.

The division of Pharmacoepidemiology & Clinical Pharmacology consists of a multidisciplinary team of young and internationally oriented researchers. The research programme is directed at several epidemiological, therapeutic, and policy aspects of chronic drug use with a focus on advanced affordable biomolecular and cellular therapies.

The Centre for Pharmaceutical Policy and Regulation is embedded in the Division. Its mission is to develop new methods for independent policy and regulatory research, evidence based policy scenarios, bridging Health Technology Assessment from population level to individualized medicine, and outcomes of reimbursement recommendations on (bio)pharmaceuticals throughout the world. Pharmacovigilance and risk management of biopharmaceuticals, policy aspects of access, innovation, traceability of (often expensive, orphan) biopharmaceuticals is an important research theme of the Centre. The Centre nurtures a strong programme in drug regulatory science that is unique in its alignment with high-profile public health, policy, and regulatory environments communities (MEB, EMA, FDA, WHO, ZIN, EUnetHTA).

The core task of the PhD candidate will be to study the regulatory barriers and facilitators for conducting RDCT within the current European regulatory framework. You will study the current EU regulatory landscape relevant to conducting RDCTs as well as the national implementation of these. In addition, you will study trust in clinical data generated by these new innovative technologies by regulators as well as views of other stakeholders, including patients, when it comes to benefits and drawbacks of conducting RDCTs. To accomplish these goals, you will engage with sponsors, regulators, policy makers, health care professionals and patients and apply both qualitative and quantitative research methodologies in these analyses.

The PhD candidate’s principal duty is to conduct scientific research, resulting in a PhD thesis at the end of the appointment. Other duties may include supporting the preparation and teaching of Bachelor's and Master's level courses, supervising student theses, managing research infrastructure and participating in public outreach. This position presents an excellent opportunity to develop an academic profile.

Specifications

Utrecht University

Requirements

You are an ambitious and creative candidate who:
  • holds an MSc degree in Pharmacy, Medicine, Innovation Sciences or other relevant biomedical field;
  • has a strong interest in pharmaceutical development or drug regulatory science;
  • experience with clinical trial conduct;
  • has experience with applying qualitative research methodologies;
  • has scientific creativity and productivity and can think conceptually;
  • is able to work within multidisciplinary teams;
  • is fluent in English.

Conditions of employment

  • be part of a great team of excellent researchers; 
  • a full-time position for 4 years; 
  • the gross salary starts at €2,325 in the first year and increases to €2,972 per month in the fourth year during the appointment (scale P according to the Collective Labour Agreement Dutch Universities (cao)). The salary is supplemented with a holiday allowance of 8% and an end-of-year bonus of 8.3% per year;
  • pension scheme, partially paid parental leave, and flexible employment conditions (based on the Collective Labour Agreement Dutch Universities).


In addition to the employment conditions laid down in the cao for Dutch Universities, Utrecht University has a number of its own arrangements. For example, there are agreements on professional development, leave arrangements and sports. You are also given the opportunity to expand your terms of employment yourself via the Employment Conditions Selection Model. This is how we like to encourage you to continue to grow. More information about working at the Faculty of Science can be found here

Employer

The Utrecht Institute for Pharmaceutical Sciences (UIPS) is the research institute of the Department of Pharmaceutical Sciences of Utrecht University. UIPS focuses on processes around discovery, development, and use of drugs and medical nutrition using molecular and technological principles from the Natural and Life Sciences. This research is ideally positioned in the Faculty of Science to work on basic scientific problems and to translate new findings into potential solutions to urgent societal medical needs, which are addressed in the Faculties of Medicine and Veterinary Medicine. Every year around 400 peer-reviewed articles are published and around 30 PhD candidates defend their thesis. UIPS is partner in several open source innovation networks.

At the Faculty of Science there are 6 departments to make a fundamental connection with: Biology, Chemistry, Information and Computing Sciences, Mathematics, Pharmaceutical Sciences and Physics. Each of them is made up of distinct institutes which work together to focus on answering some of humanity’s most pressing problems. More fundamental still are the individual research groups - the building blocks of our ambitious scientific projects.

Utrecht University is a friendly and ambitious university at the heart of an ancient city. We love to welcome new scientists to our city - a thriving cultural hub that is consistently rated as one of the world’s happiest cities. We are renowned for our innovative interdisciplinary research and our emphasis on inspirational research and excellent education. We are equally well-known for our familiar atmosphere and the can-do attitude of our people. This fundamental connection attracts Researchers, Professors and PhD candidates from all over the globe, making both the University and the Faculty of Science a vibrant international and wonderfully diverse community.

Specifications

  • PhD; Research, development, innovation
  • Natural sciences
  • 36—40 hours per week
  • €2325—€2972 per month
  • University graduate
  • 1098178

Employer

Location

Domplein 29, 3512 JE, Utrecht

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