Director of Clinical Trials
Spectracure AB / Apotekarjobb / Lund
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SpectraCure AB is a medicaldevicecompanyactive in the area of cancer treatment. We are nowhiring an experiencedclinical trial manager to headourclinicalactivities. Initiallyhe/shewillmanage the trials on his/herowntogether with localCRO's. Later weanticpate the person to head the team for whichshe or hewillrecruit.
The tasks willinclude:
• coordinating all activities at the sponsors, clinical sites, and local CRO
• being the primarypoint of contactbetween sponsor, clinical sites and CRO
• handling logisticssuch as transporting equipment and organizing meetings
• have an overview of regulatory matters and informabout and perform or delegateregulatory tasks as required
• establishingprojectdescriptions and plans
• achievingprojecttargets - time, quality, bottom line etc.
• establishing and follow up project budgets
• all project interface such as, but not limited to company organisation, subcontractors etc.
• management of, but not limited to projectcrew/personnel, subprojects, subcontractors and municipalities
• progressingprojectreporting, time cost and quality
• keepingtrack of deviations (additionalworks/delays etc.)
• detailed and overall planning of all activitieswithinprojects
• assuring that quality management system will be followed
• assuring that the health and environmentalpolicies are followed
• assuring that set project standard/qualitywill be implemented
• all logistics
• informinghimself/herself of project progress and changes
Supporting and advising the management of the company in regulatory matters
Profile:
• Previousexperience in clinical trial management in medicaldevice and/or drugdevelopment. Experience in both is considered a plus.
• Experience in clinicaltrials in USA and/or Canada is considered a plus.
Experience in manageing international multi site trialsconsidered a plus
• The Project Manager shall be capable to work under uncertainconditions. She/heshallhave the ability to prioritise and handle multiple tasks under heavy and demandingworkload. She/he is goal-oriented, self-motivated and committed to the successfuloutcome of the project. It is alsoimportant to accept that it willexist a number of issues to be solved and trying periods of time in the project start-upphase as well as along the project. She/he must also be flexible to travel and additionalworkinghours.
• The Project Manager shallalso be able to manage and encouragepersonnel in a professionalmanner. Excellent skill in English is needed.
Experience:
• A senior person with severalyears of experience in managingprojects. The Project Manager shallalso be wellaware of the Medical Device market.
For more information, pleasecontact CEO Masoud Khayyami 0708 15 21 90 or CTO Johannes Swartling 0708 23 36 80 and visit ourwebsite
www.spectracure.com.Publiceringsdatum2011-12-01Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2011-12-15
Pleasesend your jobapplication to Masoud Khayyami
mk@spectracure.com by 15th December.
Ansökan kan skickas till e-postadress:
mk@spectracure.comFöretagSpectracure AB
AdressSpectracure AB
22643 LUND
KontorsadressMagistratsvägen 10
KontaktuppgifterTelefonnummer: 046-162070
Jobbnummer 1095077
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