Trial Manager for a European investigator-initiated clinical trial

Updated: 8 months ago
Deadline: The position may have been removed or expired!

The Department is organized in 10 divisions: Obstetrics and Gynecology, Pediatrics, Pediatric Endocrinology, Pediatric Surgery, Neuropediatrics, Pediatric Oncology, Neonatology, Reproductive Endocrinology, Neuropsychiatry (KIND), Reproductive and Perinatal Health. The divisions have separate scientific profiles and vary in size and have several research groups, dealing with both basic and clinical science.

The Childhood Cancer Research
A well-established unit that consists of several research groups, all focusing on different aspects of childhood cancer research.

The head of one of these research groups, has been appointed Principal Investigator (PI) for a large European consortium, formed to design and carry out an investigator-initiated clinical trial for acute lymphoblastic leukaemia (ALL) in children and young adults. The consortium consists of five study-groups representing nine countries (NOPHO – Sweden, Denmark, Norway, Finland, Iceland, Lithuania; UKALL – United Kingdom; DCOG – the Netherlands; COALL – Germany; BSPHO – Belgium) with considerable experience in the design of such studies.

Job description
The Trial Manager will assist the PI in all aspects of preparing and running the protocol including:
1) Preparation: a) Organisation of the study-group work (coordinate meetings, take minutes, compile working-material etc) b) Aid in writing the protocol: edit the scientific part, collect background information and review regulatory demands, coordinate and write risk-assessment, monitoring-plan and data-management-plan as well as SOPs where needed. Furthermore, the candidate will assist in writing and submitting applications to the ethical review board as well as coordinate the application to the medical products agency (Läkemedelsverket).
2) During the trial: Organize administrative routines for the smooth running of the trial – prepare and distribute updates and amendments, collect and prepare safety reports such as DSURs and manage help-desk administration.

Personal qualifications
We are looking for a highly motivated candidate to join our team at the start of this exciting new European collaboration. You will be a key part of the development of the clinical trial, which, when successful will lead into the role as trial manager during the trial. Adequate training in science and GCP is necessary as well as robust experience from work in clinical trial environments, preferably with regulatory aspects. Experience from investigator-initiated studies is desirable. The candidate needs to have good communication and coordination skills as well as good simultaneous capacity. It is important to be able to work both independently and as a part of a team as well as a wider network, sometimes under time-pressure. Communication and all documentation within the consortium is naturally in English, but communication with authorities and Swedish officials will be facilitated if the candidate has the corresponding knowledge of Swedish. The ability to interact socially and scientifically with others is important.

Minimum requirements
Academic basic training (BSc-level or equivalent) in life sciences or a degree in nursing combined with research training/experience,
Adequate documented GCP-training and experience with work according to GCP.
Several years of working experience from Clinical Trials preferably including regulatory functions. Excellent written and spoken English.

Additional preferred experience
Experience in the voluntary harmonized procedure – VHP for regulatory approval
Experience from multi-country, multi-centre studies
Experience from investigator-initiated clinical trials
Good written and spoken Swedish

Application process
The application is to be submitted on the MyNetwork recruitment system.

Employment title will be Project Coordinator.

View or Apply

Similar Positions