PHAMOS is currently searching for
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CRAs Contract Research Associates for clinical trials on medicinal products, Prague-based operation in CR and SK |
Project Manager Project manager for conducting clinical trials in CR and CEE, Prague-based |
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| Responsibilities |
£ Site initiation and trial staff training £ On-site monitoring ac. to ICH-GCP, incl.
trip planning, in-house preparation, reporting and follow-up £ Interim contacts with trial sites by phone
and in writing £ Remote monitoring (RDC) or in-house check
and transfer of paper CRFs to data management £ Data clarification (queries) as requested by data management £ SAE reporting incl. translations as required £ Supply management (site level) £ Reporting to project manager, participation in regular project meetings, tele-conferences, training
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£ Primary
contact person for the sponsor £ Feasibility surveys, grant estimates,
contracting £ Selection, set-up and release of trial sites
ac. to ICH-GCP (in co-operation with the CRAs in charge) £ Request for CT authorisation, application
for EC votes, dealing with objections £ Organisation of investigator meetings,
presentation and training lectures £ Set-up of a monitoring plan, supervision of
monitoring activities, continuous on-the job training of CRAs, review of
reports, project group meetings £ Supervision of subcontractors’
performance as e.g. central lab, courier etc. £ Supervision of SAE; SUSAR reporting to
authorities, EC’s and investigators £ Translations of essential documents |
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Operation area |
Prague- based operation in the Czech Republic, perhaps Slovakia, too |
Prague- based, for projects in CR and CEE-countries |
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Education |
MD with previous working experience as physician and specialisation preferred but young MDs as well as other natural sciences suitable, too |
MD (previous working experience as physician and specialisation preferred) |
| Training | experience as CRA appreciated but newcomers welcome, too; training on the job provided | experience in organising clinical trials; experience as (senior) CRA appreciated |
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Demands |
fluent English communication skills, (native) Czech or Slovak, driving license, experience with standard office programs (user level), general organisational skills |
fluent English communication skills, (native) Czech or Slovak, driving license, experience with standard office programs (user level), general organisational skills, leading personality |
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Employment status |
freelance or employee (both possible), min. 0,5 FTE up to full time |
employee, min. 0,7 FTE up to full time |
| Salary | depending on education and experience | depending on education and experience, negotiable |
| Start | immediately but a later start could be agreed upon, too | upon agreement |
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Application |
in writing + CV (English) to PHAMOS CEE s.r.o., Dr. M. Frank, Na Poříčí 30, 110 00 Praha 1 or by email + attachments to praha@phamos.cz |
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| Team work | Join our pleasant and friendly working environment in a small CRO, supported by modern office facilities and project assistants. Team- work for international clients on demanding projects, in direct contact with your project manager and director for the sake of immediate decisions and assistance. Although objective- and profit- driven we will respect you as an individual contributing to the group's success. | |