Trial Manager (Postdoctoral Researcher) – MEVA Trial

Copenhagen Trial Unit, Rigshospitalet, Copenhagen

The Copenhagen Trial Unit (CTU) at Rigshospitalet invites applications for a full-time position as Trial Manager (Postdoctoral Researcher) for the MEVA trial (Middle Ear Ventilation in Acute Otitis Media), funded by the Independent Research Fund Denmark (DFF).

The position is available from April 1st and is time-limited in accordance with the grant period, which is until November 2028.

About the MEVA Trial

The MEVA trial is an investigator-initiated, multinational, multicentre randomized clinical trial designed to evaluate the efficacy and safety of tympanostomy tube insertion in children under 36 months diagnosed with recurrent acute otitis media (RAOM).

The trial addresses a clinically significant evidence gap regarding the benefits and harms of surgical intervention in early childhood and aims to provide robust, methodologically rigorous evidence to inform clinical guidelines and shared decision-making.

The study is conducted across sites in Denmark, Finland, and Brazil, in close collaboration with the Federal University of Rio de Janeiro and the University of Helsinki, integrating primary care, otolaryngology, anaesthesiology, and trial methodology expertise.

Responsibilities

The Trial Manager will assume primary operational responsibility for the coordination and execution of the MEVA trial across all participating countries. The role requires methodological proficiency, clinical domain expertise, and the ability to manage regulatory and logistical complexity in a multinational setting.

Key responsibilities include:

• Strategic operational planning and execution of a large-scale randomized clinical trial in accordance with ICH-GCP standards
• Coordination of recruitment pathways involving primary care, paediatrics, ENT and surgical departments
• Oversight of trial conduct at sites performing tympanostomy procedures under general anaesthesia
• Harmonisation of trial procedures across diverse healthcare systems and regulatory frameworks (EU and Brazil)
• Preparation and submission of regulatory and ethics applications in multiple jurisdictions
• Development of monitoring strategies, data quality assurance processes, and risk-based monitoring plans
• Close collaboration with statisticians and methodologists at the Copenhagen Trial Unit
• Supervision and training of local investigators and study personnel
• Contribution to high-level scientific dissemination and peer-reviewed publications

The position requires substantial international coordination and frequent interaction with investigators in three countries.

Qualifications

We seek a candidate with a combination of clinical, surgical, methodological, and international research competencies:

• Medical degree (MD or equivalent)
• Specialist certification in general practice and/or anaesthesiology (preferably both)
• Direct clinical experience in the diagnosis and management of acute otitis media in young children
• Familiarity with the surgical and perioperative context of tympanostomy tube insertion
• A strong background in Public Health (at least master’s degree) with a Global Health focus
• PhD in Clinical Medicine or related health sciences
• Documented experience in the design, conduct, and reporting of randomized clinical trials
• Solid understanding of epidemiology, bias control, outcome measurement, and pragmatic versus explanatory trial design
• Strong knowledge of regulatory processes in both European and Brazilian research contexts
• Legal residence and work authorization in Denmark and Brazil

Given the multinational structure of the trial, it is essential that the candidate:

• Has established academic collaboration with the Brazilian institutions involved in the trial (the Federal University of Rio de Janeiro and others that may join the trial in the future)
• Possesses in-depth knowledge of Brazilian clinical and ethical regulatory systems
• Is fluent in English and Portuguese
• Has proficiency in Danish (completion of state language training through module 5; PD3 assessment undergone or underway)
• Additional language skills are considered advantageous

We Offer

• A leading role in a high-impact, DFF-funded international randomized clinical trial
• A research environment with strong methodological expertise at the Copenhagen Trial Unit
• Close interdisciplinary collaboration between primary care, surgery, anaesthesiology, and trial methodology
• Opportunities for scientific leadership, authorship, and academic career progression

Terms of Employment

Employment will follow the collective agreement for academic staff in Denmark. The position is based at Rigshospitalet, Copenhagen, with expected travel to collaborating sites in Finland and Brazil.

Applications must include:

• Cover letter
• Curriculum vitae
• Documentation of academic degrees
• List of publications

Application deadline March 20th.

For further information, please contact Head of Centre Janus Christian Jakobsen, Copenhagen Trial Unit, Rigshospitalet.

• Fakta

• Arbejdssted
  Rigshospitalet, Blegdamsvej
• Kontaktperson
  Janus Christian Jakobsen
  janus.christian.jakobsen@regionh.dk
• Adresse
  Blegdamsvej 9, 2100 København Ø
• Stillingstype
  Forsker
• Speciale
  Oto-rhino-laryngologi
• Ansættelsesform
  Tidsbegrænset periode
• Ugentlig arbejdstid
  Fuld tid
• Ansættelsens start
  Snarest muligt
• Regionens jobnr.
  267505
• Quick-nr.
  488825
• Indrykningsdato
  09-03-2026
• Ansøgningsfrist
  23-03-2026