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stillingsbetegnelse: Clinical Trial Manager for Oticon Medical

jobbeskrivelse:

We offer you a chance to join Oticon Medical for an exciting opportunity within the Clinical Affairs team. You will help us build clinical documentation for our current Bone Anchored Hearing System (BAHS) and new developments. You can also look forward to being a part of bringing completely new products to the market – and work with the clinical trials that allows that.

 

You plan and conduct clinical trial activities

As Clinical Trial Manager, you play a key role with responsibility for planning and conducting external clinical trial activities with focus on BAHS sound processors and audiological aspects to help us ensure that our clinical documentation meets relevant requirements and standards. You are based at Oticon Medical in Smørum, Denmark where you will become part of an interdisciplinary environment at Oticon Medical’s offices in Gothenburg and Copenhagen. Furthermore, you will work 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 documentation and clinical trials.

 

Summed up, you will be responsible for the following tasks:

• Design clinical trials within the area of BAHS sound processors and audiology
• 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 varying, stretching from planning to the hands-on execution of clinical trials.

You can expect 20-30 days of business travel per year.

 

What we would like to know about you?

The ideal candidate will have the following qualifications:

• Relevant academic background (typically a Master’s degree in audiology, biomedicine, 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 withpost-market clinical trials
• Experience in monitoring
• Very good working knowledge of relevant regulations, e.g. ISO14155, relevant MEDDEV’s, MDD/MDR
• Experience in documenting clinical trials
• As corporate language is English, we expect you have good communication skills, and speak and write English proficiently

 

Moreover, we hope to see the following skills in your CV:

• Previous work in an Clinical Affairs  setting
• Research experience in a relevant academic field
• Statistical knowledge and skilled at statistical analysis
• Knowledge of bone anchored or other hearing devices (not mandatory)

Experiences from negotiating contracts on clinical studies

We believe that the best results come from a fruitful team effort, and it is important that you consider yourself as a team player who finds it inspiring to discuss challenges with colleagues, but who can also initiate and conduct tasks independently. We have an informal and creative atmosphere where mutual respect is pivotal, and we strive for the common goal.

You have a scientific approach, and you also acknowledge the business point of view. You are pragmatic, have an eye for detail but never lose the overview. You get things done.

Even if you don’t have all competences and experiences above, we would like to hear from you. There will be possibilities for the less experienced candidate to grow with the tasks.

 

We believe in the good life

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. Personal and professional development is the foundation for the growth of our business. Simple as that.

We create solutions that allow people to live their lives to the fullest. We also recognize in order to bring energy and inspiration to work, you need to re-energize and spend time with family, friends and hobbies in a healthy work life balance.

 

Application and contact

To learn more about the job, please contact Senior Director, Clinical Audiology and Research, BAHS, Tove Rosenbom (tvro (at) oticonmedical.com phone: +45 2428 3462).  Please send your application and CV online only and not later than 30th October 2018.

Application can be provided in English, Swedish or Danish. Read more about Oticon Medical on http://www.oticonmedical.com

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C1219

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: OTICON A/S

source: DK-STAR