Senior Clinical Research Associates (m/f) Linical Europe GmbH Frankfurt am Main, Thalfingen you will be responsible for clinical monitoring activities and managing clinical study sites in the DACH-region;... co ltd ('') is a premier global cro headquartered in osaka japan listed in the prime segment of the tokyo stock exchange and dedicated to serve its clients as a true partner in development with approximately 500 employees directly covers a total of more than 20 countries in north america and asia-pacific including japan via its own offices and staff 's an arm is headquartered in frankfurt germany with a substantial presence in paris and madrid its geographic footprint facilitates a significant presence in the leading western an markets combined with well-established affiliate operations in key emerging markets in central- and eastern we offer individualized solutions that are tailored to the specific needs of our sponsors we work as integrated teams functioning with maximum transparency throughout each study making sure that the sponsor is kept up to date on all study parameters and progress we are dedicated to the highest standards of quality with a special focus on the therapeutic areas oncology immunology and cns based on experience and expertise for our further dynamic and successful company growth is seeking several well-experienced senior c research associates (m/f) location: office-based in frankfurt thalfingen (near ulm) or homebased in this challenging position you will be responsible for c monitoring activities and managing c study sites in the dach-region ensuring quality service and appropriate c study conduct job details: ensure that the conduct of the study is in compliance with the currently approved study protocol/amendment(s) with ich gcp sops and any applicable regulatory requirements in the assigned countries conduct any kind of on-site monitoring visits (pre-study initiation routine monitoring site closure) review of and/or input to the study protocol crf and validation tools preparation and/or review of monitoring guidelines crf completion guideline patient information documents preparation of submissions to independent ethics committees (central and local) and to competent authorities assisting of investigator and institution contracts negotiating budgets and arranging site payments query management in cooperation with the c data management team assisting sites and the study team in managing contacts to external service providers such as central laboratories participation in feasibility studies and investigator selection responsibility for site management as an ideal candidate you should have the following profile: university degree in sciences or related fields nursing degree or comparable education and experience and knowledge of c trials and regulations business level german and conversational english language any additional language skills are appreciated at least 3 years' experience in c monitoring in a pharmaceutical company or a cro sound knowledge of relevant guidelines (eg ich gcp) and regulatory requirements strong team player combining communication and organizational skills willing and happy to travel approx half of your working time on average are you ready for the challenging and exciting work within an international team in a well-established but also fast growing cro are you target-driven used to sharing your expertise with a team and always focused on the team's success we offer a competitive salary and benefit package reflecting your level of experience we look forward receiving your application detailing your availability and salary expectations please send your application to: http://wwwcom/join-our-team/ or by e-mail to: hreu@com Forschung Naturwissenschaftler Medizin Arzneimittelprüfung Arzneimittelrecht Krankenpfleger Krankenschwester Pharmazie Pharmaunternehmen Studien Zulassung Qualitätsmanagement Klinische Studien Forschung Naturwissenschaftler Medizin Arzneimittelprüfung Arzneimittelrecht Krankenpfleger Krankenschwester Pharmazie Pharmaunternehmen Studien Zulassung Qualitätsmanagement Klinische Studien Senior Clinical Research Associates (m/f) you will be responsible for clinical monitoring activities and managing clinical study sites in the DACH-region Frankfurt am Main Thalfingen Forschung Naturwissenschaftler Medizin Arzneimittelprüfung Arzneimittelrecht Krankenpfleger Krankenschwester Pharmazie Pharmaunternehmen Studien Zulassung Qualitätsmanagement Klinische Studien



Die Stellenanzeige Senior Clinical Research Associates (m/f) von Linical Europe GmbH wurde zuletzt aktualisiert am 03.02.2016.



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