OPEN POSITION: Medical Device Clinical Trial Manager

30.11.2020

Are you looking to join a dynamic and innovation-driven start-up that is building a healthier future for us all? Askel Healthcare’s unique technology rebuilds damaged joint surfaces for pain-free movement. With our implantable medical device solution, patients can quickly regain normal levels of activity free of pain. The drive, competence and dedication of our people make us unique. Positive attitude towards life in its all shapes and colors – is the core value we live by. 

We are now looking for a Clinical Trial Manager to join our team in Helsinki, Finland. 

Our vision is to provide everyone a good quality life free of pain. A good quality life is a life where you are not restricted by your body to do things you love. We aim to offer the best treatment option for early cartilage regeneration to prevent further joint degradation and osteoarthritis. We at Askel do not stop at treating symptoms; we go a step further and provide truly regenerative solutions for the long-term benefit of the patients. 

 

Greetings from your future manager: 

“We are looking for an experienced person with a can-do attitude to design and lead the clinical trials of our core product COPLAIf you have strong project management skillscapability to motive and lead people to succeed and perseverance to carry our complex tasks - we warmly welcome you to join the team and the amazing ride of bringing a novel treatment solution to the market.” – Dr Virpi MuhonenChief Executive Officer, Co-founder, Askel Healthcare 

 

What you’ll do 

In this position you will be responsible for: 

  • Leading the designbudgetingexecution, closure and reporting of clinical trial for a class III medical device according to all applicable regulations and guidance and company Standard Operating Procedures 
  • Proactive operational management of the clinical trial to ensure achievement of study milestones within the budget and timelines 
  • CRO and vendor selection, contracting, oversight and management 
  • Management of clinical contracts, e.g. Clinical Site Agreements 
  • Managing recruitment efforts and activities to meet study enrolment goals and timelines 
  • Providing leadership and coordinating the teams at investigative sites 
  • Foster and maintain strong working relationships with KOLs and staff located at investigative sites 
  • Develops, reviews, and approves study-related manuals, plans, specifications, charters, newsletters, and materials 
  • Providing input on risk mitigation plans and assessment according to ISO 14971 
  • Acting as the main line of communication; obtaining and relaying key study issues, status updates and other study information to the key stakeholders and company’s management 
  • Performing other work-related duties as assigned or required 

 

What is your professional profile: 

(Can you say ‘yes!’ to a bunch of these?) 

  • Minimum Master’s Degree in health care, biomedical sciences or engineering, life sciences or other relevant educational background 
  • Relevant clinical trial management experience within industry (preferably class III medical devices) 
  • Strong experience in project management and budgeting 
  • Experience in selection and oversight of external vendors 
  • Experience in management and monitoring of CRO and investigative sites 
  • Experience with patient recruitment, non-compliance, safety, document management, IP accountability, and budget management 
  • Broad understanding of clinical trials design, processes and protocols 
  • Broad knowledge of MDR, local regulatory authority regulations, legislation and procedures 
  • We also value knowledge and experience in a) US regulatory requirements, especially pre-market approval of class III medical devices, b) orthopedics, c) company’s focused therapeutic area, d) what else should we value – you tell us! 

 

Who you are as a person: 

  • Possess a high degree of professionalism, maturity and confidentiality 
  • Excellent organization and management skills 
  • Effective communication skills, both verbal and written 
  • Results oriented 
  • Ability to work cross-functionally 
  • Ability to build relationships with external parties (suppliers, regulatory agencies, etc.) 
  • Motivated to work in a fast-paced, high accountability and somewhat ambiguous start-up environment 
  • Foster a culture of collaboration, partnership, teamwork, customer service, and a drive for change and continuous improvement 
  • Fluent written and spoken English, Finnish is seen as a benefit 
  • Willingness to travel 

 

This iwhat woffer for you: 

  • Meaningful job: Our work impacts the quality of life of millions of people and companion animals in future. We highlight the expertise of our personnel, the high quality of our products and the company values. 
  • Inspired and motivated team: We have highly skilled and dedicated workforce that works as a team to achieve our shared objectives. 
  • Development opportunities: With us you can build up your expertise. We provide opportunities to support your development throughout every stage of your career. The sky is the limit for your professional growth! 

 

Additional Information: 

  • For more information, please contact Virpi Muhonenv.muhonen@askelhealthcare.com, tel. +358 40 489 3840 
  • Preferable times for a call Monday 14.12.2020 at 13:00-15:00 and Monday 11.1.2021 at 13:00-15:00 (UTC+2) 
  • Please send your application letter, including salary request (max 1 page) and CV (max 2 pages, containing only information relevant to the position) as a pdf document to v.muhonen@askelhealthcare.com at latest by 15.1.2021 
  • We will start going through the applications already during the application period, so please submit your application as soon as possible 
  • It is essential that applicants hold entitlement to work in Finland 
  • The work title, responsibilities and compensation are negotiated based on the applicants previous experience 
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