Trial Manager for a European investigator-initiated clinical tri
Karolinska Institutet, Department of Women's and Children's Heal / Organisationsutvecklarjobb / Solna
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hela Sverige 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.
Karolinska Institutet is one of the world 's leading medical universities. Its mission is to contribute to the improvement of human health through research and education. Karolinska Institutet accounts for over 40 per cent of the medical academic research conducted in Sweden and offers the country 's broadest range of education in medicine and health sciences. Since 1901 the Nobel Assembly at Karolinska Institutet has selected the Nobel laureates in Physiology or Medicine.
Pursuant to the regulations of the Swedish National Archives, applications are kept on file for two years after the appointment has gained legal force. The regulations do not apply to attachments that have been printed or otherwise published.
Karolinska Institutet strives to provide a workplace that has approximately the same number of women and men, is free of discrimination and offers equal opportunity to everyone.
For temp agencies and recruiters, and to salespersons: We politely, yet firmly, decline direct contact with temp agencies and recruiters, as well as those selling additional job announcements.
Varaktighet, arbetstid
100 %. Tillträde: Upon agreement Visstidsanställning
Publiceringsdatum2016-12-19ErsättningMonthly salary
Så ansöker duSista dag att ansöka är 2017-01-15
Ange följande referens när du ansöker: 2-5219/2016
Klicka på denna länk för att göra din ansökanKontaktDésirée Gavhed, Coordinator 08-517 728 70
FöretagKarolinska Institutet, Department of Women's and Children's Heal
AdressKarolinska Institutet, Department of Women's and Children's Heal
Byggnad H2:00, Karolinska Universitetssjukhuset
17176 Stockholm
KontorsadressByggnad H2:00, Karolinska Universitetssjukhuset
Jobbnummer 3220397
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