Clinical Trial Manager (maternity cover)

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 May, 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 being part of bringing new products to the market – and work with the clinical trials that allows that.


The position is based at Oticon Medical AB in Askim, Sweden.
 
You plan and conduct clinical trial activities
As Clinical Trial Manager (12 month temp), 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. 
 
How to apply
To learn more about the job, please contact Acting Director, Clinical Affairs, Surgical Systems, Ulrika Petersson (ulpe@oticonmedical.com: phone: +46 70 295 62 72). Please send your application and CV before March 29, 2020 via www. oticonmedical.com. 
 
Recruitment agency? Thank you for your interest, but we are sourcing all our candidates directly or via our preferred suppliers. We appreciate you trying but please keep in mind that any unsolicited profiles you send us will be treated as direct applications from the candidates.