Clinical Trial Manager (Maternity Cover)
Oticon Medical AB / Apotekarjobb / Göteborg
2015-12-07
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hela Sverige Visa alla jobb hos Oticon Medical AB i Göteborg About Oticon Medical Oticon Medical is part of William Demant Holding with more than 11.000 employees across the world and revenues of over DKK 11 billion. Oticon Medical is a market leading manufacturer of bone anchored and cochlear implant hearing systems for children and adults. At Oticon Medical we combine more than a century of experience in audiology and sound processing from Oticon with decades of pioneering experience in hearing implant technology. Our connection to Oticon gives us unique access to knowledge, resources and technology that we use for developing innovative and life-changing implantable hearing systems.
Now you get the chance to join Oticon Medical for an exciting opportunity within the area of clinical trials. You will help us build clinical documentation for our current Bone Anchored Hearing System (BAHS) and new developments. You can also look forward to be part of bringing completely new products to the market - and work with the clinical trials that allows that. Based at Oticon Medical AB in Askim, Sweden you will become part of an interdisciplinary environment at Oticon Medical's offices in Gothenburg and Copenhagen, Denmark. You plan and conduct clinical trial activities In your new temporary position (1 year) as a Clinical Trial Manager, you play a key role with responsibility for planning and conducting external clinical trial activities with focus on BAHS implants and surgical aspects. You work closely together with our R&D, QA/RA and marketing groups. You also take part in building relationship with and connecting to researchers in the field. Moreover, you will be involved in further improvements of the internal processes and procedures for clinical trials. Summed up, you and you two closest colleagues will be responsible for the following tasks: . Design clinical trials within the area of BAHS implants and surgery . Write study protocols and case report forms . Write documentation for study approval by ethical committee and competent authorities . Ensure documentation for clinical trials are complete and up-to-date . Ensure or carry out relevant monitoring activities . Perform data management tasks . Analyze data and conduct statistical analyzes . Take part in developing our procedures for clinical trials and related activities Besides the above mentioned, we give you the opportunity to further develop in our company as our product range and Oticon Medical grows. Your profile will help deciding the exact tasks you will work with, but the job will be extremely varying, stretching from strategic directions to the hands-on execution of clinical trials. You can expect 20-40 days of business travel per year.
The ideal candidate will have the following qualifications: . Relevant academic background (typically a Master's degree in biomedicine, biomaterials, engineering or similar) . Experience with designing and preparing documentation for clinical trials of medical devices, ideally having worked in an implant company or CRO . Experience with both pre- and post market clinical trials . Experience in monitoring . Good working knowledge of relevant regulations, e.g. ISO14155 . Experience in writing publications . Good communication skills, and speak and write English proficiently Moreover, we hope to see the following skills in your CV: . Previous work in an R&D setting, where products and ideas are constantly evolving . Knowledge of bone anchored or other hearing devices . Statistical knowledge and skilled at statistical analysis . Experiences from negotiating contracts on clinical studies . Hands-on experience with FDA PMA process . Research experience in a relevant academic field We are looking for a team player who finds it inspiring to discuss challenges with colleagues, but who can also initiate and conduct tasks by him/herself. You have a scientific approach, and you also acknowledge the business point of view. You are pragmatic, results oriented and get things done. You have an eye for the detail as well as an overview.
Varaktighet, arbetstid
Visstidsanställning 6 månader eller längre
Heltid
The offer is a 12 month maternity cover
Publiceringsdatum2015-12-07Tillträde2016-01-01
ErsättningFast månads- vecko- eller timlön
Så ansöker duPlease send your application and CV via
Klicka på denna länk för att göra din ansökan . Application can be provided in English, Swedish or Danish. Read more about Oticon Medical on
Klicka på denna länk för att göra din ansökanKontaktMarcus Holmberg, Clinical Trial Manager
mhol@oticonmedical.comFöretagOticon Medical AB
AdressOticon Medical AB
Datavägen 37B
43632 ASKIM
Övriga kontaktuppgifterTelefonnummer: +46317486100
E-postadress:
mhol@oticonmedical.com Jobbnummer 2562903
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