Collaborating Expert on clinical trial registry data to target priorities in TAs

Strategic area / objective

The Accelerating Clinical Trials in the European Union (ACT EU) initiative will support smarter clinical trials through regulatory, technological and process innovation.

The vision of ACT EU is to transform the EU into a region that supports clinical trial development and enables collaboration and innovation at all stages of the clinical research lifecycle.

As part of their remit the EMRN (European Medicines Regulatory Network) maintains registers which contains information on all proposed and ongoing clinical trials on medicines. These registers provide information about clinical trials, sometimes called “clinical trial characteristics” or “clinical trial metadata” and do not contain the individual patient data. 

Typically, they are used to support regulatory decision-making, but their potential uses extend far beyond that scope. Academics for instance might want to track the uptake of innovation, or might use the research context they provide to support the generation of clinical evidence on topics within their field.

Specific projects

•    Identification of an impactful research need/priority within a therapeutic area which may be supported by smart use of data held within EU clinical trial registers.
o    The expert is expected to propose a scientific topic which is considered relevant in their field.
o    Together with EMRN colleagues a research question will be formalised.
o    Methodology should include the use of the registry data to support its investigation.
•    Collaborate and engage the relevant technical and scientific EMRN colleagues, including through ACT EU and related fora.
•    Disseminate the key findings through a presentation and subsequent publication in a peer-reviewed scientific journal.
•    Depending on candidate background, opportunity for use of advanced analytics for the retrieval and analysis of the necessary data. 
 

Deliverables

•    Presentation of key findings to ACT EU fora, which may include the ACT EU multi-stakeholder platform advisory group.
•    Dissemination to the scientific community via presentation and publication in peer-reviewed journal.
 

Benefits for the expert

•    Developing scientific and technical approach for addressing academic needs through EMRN infrastructure.
•    Gain experience or knowledge of working in an EU organisation and of the EMA’s work.
 

Benefits for the collaborating institution

•    Establishing or strengthening a dialogue between academic and regulators on a scientific topic
•    Building a personal and inter-institutional collaboration with EMA, while exploring areas of mutual interest.
 

Essential requirements

Eligibility criteria:  
•    Be an EU or EEA national
•    Meet the requirements stated in the profile description;
•    Be a paid employee from European academia, research institutions, public sector or international organisations, or a post graduate student within such organisations. Proof of employment/student status and agreement in principle of employer/academic institution will be requested.;
•    Have a thorough knowledge of English (at least level C1). Good knowledge of another official EU language (at least B2) is an asset, as per the Common European Framework for Languages.

University degree(s)
Essential: University degree preferably in biomedical sciences, life sciences, public health.

Experience and additional skills
Essential: research and analytical skills; proven expertise within a therapeutic area; excellent written communication skills;
Desirable: Data analytics experience

Behavioural competencies
Essential:
•    Communication skills 
•    Interpersonal skills 
•    Working with others
•    Adaptability 
•    Learning and development