QARA Specialist (Clinical Trials)

QARA            ·            Barcelona, Cataluña, España (Fully remote)           ·            Full-time 

QMENTA was founded to empower the breakthroughs that will ultimately make brain diseases a thing of the past. We deliver on our vision by helping researchers, clinical trial leaders, and innovators do their work better and faster by serving as the indispensable hub for data, tools, and expertise that accelerates the understanding, diagnosis and treatment of brain diseases. How? We bring to market a powerful package of sophisticated technologies integrated into a single software solution that easily fuses big brain data with AI analytics.

As a Quality Assurance & Regulatory Affairs (QARA) specialist for Clinical Trials, you will be part of the QARA team reporting directly to the QARA Director. The QARA specialist will be responsible for ensuring that all activities related to Good Clinical Practices (GCP) when participating in Clinical Trials are performed with the highest quality and security by following all applicable standards and regulations. The QARA specialist will also be responsible for ensuring that our products meet all requirements needed for being used in Clinical Trials. You will collaborate internally with other experts on our team (executives, engineers, researchers, and the business team) to optimize our procedures.

Responsibilities

• Implementation and maintenance of our Quality Management System (QMS) in relation to Good Clinical Practices (GCP) and all applicable standards and regulations for Clinical Trials (FDA Title 21 CFR Part 11, Annex 11, GxPs, ICH:E6(R2), HIPAA, and GDPR).
• Create, maintain, and update specific Standard Operating Procedures (SOP)/WIs according to the needs of our customers and the Clinical Trials. 
• Responsible for the Documentation Control Process and Documentation Change Control Process.
• Lead internal audits of all QMENTA areas involved in the QMS for GCP.  
• Assist external audits/inspections and interact with CROs/Sponsors, health authorities, consultants, and/or auditors.
• Coordinate corrective and preventive actions, and drive resolution of non-conformities. 
• Conduct internal training and the onboarding process for all QMENTA employees involved in the execution of Clinical Trials. 
• Perform internal follow-ups at the compliance level with all QMENTA teams involved in the execution of Clinical Trials (Engineering, and Research teams).
• Assist in the vendor qualification process with our customers from the vendor questionnaire to the qualification audit. 
• Keep updated about the latest regulations and mitigate risks of the changes.
• Participate in the designing and development of QMENTA’s solutions (based on Medical Software)  
• Support the maintenance of our QMS and associated certificates according to ISO 13485, IEC 62304, ISO 14971, FDA Title 21 CFR Part 11 & Part 820, Annex 11, and GxPs.  
• Assist in the preparation of the documentation for the health authorities. 
• Keep compliance with the agreements we sign with our customers (concerning specific requirements not implemented in our systems at the quality and regulatory levels).
• Assist the different areas of the company in the evaluation of suppliers according to our supplier management SOP.

Required Skills and Experience

• At least 5 years of professional experience as a Quality Assurance & Regulatory Affairs specialist.
• Working knowledge of Quality Management System (Good Clinical Practices) and Data Integrity.
• Experience in leading internal audits.
• Previous experience in external audits with CROs and Sponsors.
• Understanding of FDA regulations for Clinical Trials. 
• Experience in the requirements needed for the execution of Clinical Trials (FDA Title 21 CFR Part 11, Annex 11, GxPs, ICH:E6(R2)).
• Experience in the software development life cycle in electronic systems for clinical trials. 
• Understanding of cloud security is a plus. 
• Experience in central review for Clinical Trials is a plus.

Skills

• Strong Communication Skills (Written & Oral) in English. 
• Detail oriented, ability to read various standards and guidelines & define implementation details.
• Excellent attention to detail and working knowledge of appropriate regulation.
• Proactive.
• Proficiency in Confluence, Jira and G-drive.
• Positive attitude toward change, and contribution to new ideas and improved ways of working.

What we offer:

• Competitive salary
• Flexible working hours
• Remote work whithin the spanish territory (spanish local contract) 
• Health insurance benefit
• Ticket restaurant
• Teambuildings 
• The chance to work for a dynamic and fast-growing company where you can make a difference

Only CVs in English will be taken into consideration.

We are an exciting and rapidly growing business where everyone works hard towards a common goal of exceeding customer expectations. We are looking for the right candidate to join us on our journey.

Follow your career aspirations to QMENTA for diverse opportunities with a company that provides the growth and strength to build your future. QMENTA is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.QMENTA.com, on Facebook at www.facebook.com/qmenta and on Twitter

Please click here to apply.