Clinical Evaluation Scientist
Clinical Evaluation Scientist Ref: 2021-004
- POSITION TITLE: Clinical Evaluation Scientist
- DEPARTMENTE: Regulatory Affairs
- CLASSIFICATION: Full time Employment
- PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid)
POSITION SUMMARY
Clinical Evaluations Scientists are an integral part of the Regulatory Affairs team. Their work is critical during the development and clinical evaluation of a new medical technology, especially where the product approval process is the heart of the whole matter, but also after the launch the medical device on the market.
Especially under the new European MDR and IVDR, it becomes more and more fundamental to know all the specific details of the clinical evaluation process of a medical device and in-vitro diagnostic product and to know exactly how this complex process works.
KEY RESPONSIBILITIES
- Accompanying development of technical documentation compliant with MDR 2017/745 or IVDR 2017/746
- Writing of medical and technical regulatory documents
- Ensure compliance with of Clinical Evaluation guidance MEDDEV 2.7.1
- Be a champion in our company for clinical evaluation of medical devices
- Provide expertise and understanding of good publication practices and guidance
POSITION QUALIFICATIONS
- Experience in Clinical Research (2 to 5 years)
- Experience with Medical Devices preferred)
- Excellent computer proficiency (Microsoft® Office)
- Author of peer-reviewed manuscripts in a medical discipline
- Good communication and organizational / time management skills
- Self-motivation with the ability to work under pressure to meet deadlines
- Detail and process oriented, positive attitude and approach, multi-tasking capability
- Knowledge of EU Directives/Regulations and clinical research standards
- Bachelor’s degree in life sciences
- Master program in life sciences
- PhD in medical discipline is preferred
- Advanced English (written and spoken)
Send a CV and coverletter to regulatory@akrnconsulting.com
Clinical Research Scientist
Clinical Research Scientist Ref: 2021-002
- POSITION TITLE: Clinical Research Scientist / Associate (CRA)
- CLASSIFICATION: Full time Employment
- PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid)
POSITION SUMMARY
Under the direction of the Clinical Affairs Manager/Clinical Operations Manager the CRA will implement and coordinate assigned projects; pre-market trials (CE mark) and post market registries in Europe, related to Class III implantable products. The CRA will perform the job according to internal and external requirements, including European medical device directives and national guidelines. The job duties involve managing all aspects of submissions to Ethics Committees; clinical trial contract negotiations; case report form (CRF) design and implementation; database management (data collection, review and query); clinical on-site monitoring; maintaining close contact with study site coordinators and investigators; and participating in congresses and external meetings as required.
KEY RESPONSIBILITIES
- Preparation of clinical protocols (and amendments), clinical trial contracts (and amendments), and case report forms
- Manage initiation of clinical sites including Regulatory and Ethics Committee submissions, and applicable training of site on protocol and CRF
- Organize investigators meetings
- Ensures adequacy of regulatory documents and in compliance with EC requirements.
- Monitoring and reporting of site enrollment progress
- Maintaining site and internal documentation in accordance with established SOPs
- Ensuring clinical trial/registry contract obligations are met in timely manner
- Serving as key contact for assigned clinical sites throughout the study
- Perform other related duties as assigned on request
POSITION QUALIFICATIONS
- Experience as Clinical Trial Assistant (minimum 2 years or equivalent)
- Experience with Medical Devices
- Excellent computer proficiency (Microsoft® Office);
- Good communication and organizational / time management skills
- Self-motivation with the ability to work under pressure to meet deadlines
- Detail and process oriented, positive attitude and approach, multi-tasking capability
- Working knowledge of EU Medical Device Directives / local regulations / ISO14155 regulations, device development, and clinical monitoring procedures
- Bachelor’s degree in life sciences
- Advanced degree (Masters or PhD) preferred.
- Familiarity with hospital environment
- English (advanced)
- Spanish
- Third language such as German or French is preferred
Send us your CV and cover letter to contracts@akrnconsulting.com
International Business Development Internship
| Business Development Internship Ref: 2021-003 |
- POSITION TITLE: Business Development Assistant
- CLASSIFICATION: Agreement with a university or business school
- PLACE OF WORK: Office-based (San Sebastian de los Reyes, Madrid)
| POSITION SUMMARY |
The role of the Business Development (BD) internship is to support international and national business development strategies to promote the AKRN consulting services. The Business Development internship supports the operational part of the company by improving access to the company´s data and then using that data to increase company efficiency and profitability. Apart from handling established customers’ details, the Business Development internship also assists to attracts new customers for the company through various promotional and advertising methods.
| KEY RESPONSIBILITIES |
Sales
- Identify, qualify and contact sales leads using market intelligence databases and provide information on products and services to generate leads.
- Maintain company CRM databases.
- Assist in the preparation of proposals and invoices
- Track the success of sales leads and following up unsuccessful proposals to determine future improvements.
Marketing
- Assist in the development and implementation of the company marketing plan.
- Undertake marketing projects as required.
- Undertake a range of marketing and promotional activities.
- Attend meetings where required.
Business Intelligence
- Collect data from internal systems and external sources, prepare it for analysis, develop and run queries against that data and create reports, dashboard, and data visualizations to make the analytical results available to corporate decision-makers.
- Assisting company executives in the identification of market trends.
- Enabling BI tools to support both company executives in strategic and tactical decision-making processes.
- Building BI dashboards and performance scorecards that display visualized data on business metrics (such as number projects, billable hours per employee, annual variability in workload)
| POSITION QUALIFICATIONS |
REQUIREMENTS
- An agreement with a university or business school is necessary for the internship
- Interest in International Business Development
- Passion for the healthcare sector.
- International consulting role spirit
- Experience driving projects
- Excellent computer proficiency
- Good communication and organizational / time management skills
- Self-motivation with the ability to work to meet deadlines
- Detail and process-oriented, positive attitude and approach, multi-tasking capability
EDUCATION
- Bachelor’s degree
- Advanced degree preferred.
PREFERRED ABILITY
- English (advanced/C1)
- Spanish (working proficiency)
- Third language is preferred.
EMPLOYEE BENEFITS
- This is an offer for an internship period of one year (an agreement with a university or business school may be necessary).
- The internship grant for the intern will be 800 net per month.
- We will provide all the necessary equipment (Laptop, screen, keyboard, and mouse)
- The employee will enjoy the employee benefits program sponsored by AKRN.
Send us your CV and cover letter to info@akrnconsulting.com
