Clinical Trial Manager (maternity cover)

Oticon Medical AB / Biomedicinjobb / Göteborg
2019-11-06
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Join us in making a difference for our users and patients within clinical trials. We are looking for someone to join us for a maternity cover starting in January, 2020.
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 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 (12 months) as a Clinical Trial Manager, you will play a key role with responsibility for planning and conducting sponsored 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 will be responsible for the following tasks:
Planning and execution of clinical trials within the area of BAHS implants and surgery
Write study documentation
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


Your profile will help deciding the exact tasks you will work with, but the job will be varying, stretching from strategic directions to the hands-on execution of clinical trials.
You can expect 20-40 days of business travel per year.

Experience with clinical trials
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 a medical device company or CRO
Experience with both pre- and post-market clinical trials
Experience in monitoring
Good working knowledge of relevant regulations, e.g. ISO14155
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
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.

Even if you don't have all competences and experiences above, we would like to hear from you.

Our offer to you
Oticon Medical offers many challenges in an international organization full of energy and expertise. The right candidate will learn very much in a short time span, since you will have the opportunity to work with all aspects of clinical trials. You will be part of an environment based on trust and openness. We offer flexible working conditions.

Application and contact
To learn more about the job, please contact Director, Clinical Affairs, Surgical Systems, Sofia Jonhede (sojo@oticonmedical.com: phone: +46763286731). Please send your application and CV via www.oticonmedical.com. NB! Deadline is 27 November, 2019
Read more about Oticon Medical on www.oticonmedical.com

About Oticon Medical
Oticon Medical is a global company in implantable hearing solutions, dedicated to bringing the magical world of sound to people at every stage of life. We are part of the Demant Group - one of the world's largest groups of hearing health care companies with more than 14,000 employees worldwide and revenues of over DKK 14 billion. We share a close link with Oticon and have direct access to the latest advancements in hearing research and technologies. Our competencies span more than a century of innovations in sound processing and decades of pioneering experience in hearing implant technology. By working collaboratively with patients, physicians and hearing care professionals, we ensure that every solution we create is designed with user needs in mind. We share an unwavering commitment to provide innovative solutions and support that enhance quality of life for people wherever life may take them. Because we know how much sound matters.

Publiceringsdatum
2019-11-06

Så ansöker du
Sista dag att ansöka är 2019-11-27
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Adress
Oticon Medical AB
Datavägen 37B
43632 Askim

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
Oticon Medical AB (org.nr 556741-3132)
Datavägen 37B (visa karta)
436 32  ASKIM

Arbetsplats
Oticon Medical AB

Jobbnummer
4943507

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