We are hiring! QUALITY ASSURANCE MANAGER (m/f)

We are currently seeking a Quality Assurance Manager (m/f) to maintain and enhance our Quality Management System (QMS) and to ensure that our products compliant with the regulatory requirements. The goal is to assure the high quality of our developments and operations aiming to the long-term success of our business.

Location

Berlin, Germany

Your Responsibilities

  • Perform overall SOP (Standard Operating Procedures) management and development,
  • Verify compliance with GCP guidelines and other relevant local and international regulations,
  • Identify and investigate quality issues,
  • Identify, develop and implement quality systems and process improvement opportunities,
  • Provide guidance to Clincase staff regarding compliance issues and SOP interpretation,
  • Develop regulatory trainings and training materials,
  • Implement proper document management and change control processes,
  • Implement CAPA management tools and strategies
  • Schedule, plan, conduct and report on internal and external audits,
  • Manage preparation for audits, represent Clincase during external audits and conduct review and strategy relating to audit results
  • Stay up-to-date, and keep management up-to-date on developments in regulatory landscape
  • Share information in an open, balanced and objective manner
  • Implement benchmarking practices and perform other tasks as needed
  • Work in close collaboration with the V&V Manager to implement a comprehensive compliance regime.

Your Profile

  • A Bachelor’s degree in life sciences, biotechnology, medicine or other related degree programs
  • 3+ years of experience in a Quality Assurance role in the life sciences industry with a demonstrated expertise in regulations affecting our industry (i.e. FDA CFR part 11 and EU Annex 11 and related guidance publications) and GCP.
  • Able to work with limited supervision, a self-starter
  • Has strong communication and organizational skills
  • Independent-minded, but comfortable working in a team environment
  • Enthusiastic about well-defined and well-implemented processes
  • Fluent in English (written and spoken)
  • Proficient in German (C1 or C2 level)

We are hiring! SENIOR ACCOUNT / PROJECT MANAGER (Dual Role) (m/f)

At Quadratek Data Solutions (Clincase) we are on a mission to change clinical trials for the better. Our goal is simple – to help pharmaceutical and bio-tech companies, universities, big or small, to get their life-altering innovations to market.

The Clinical Trial industry is ripe for change. Clinical trials are complex beasts to run. They are chock-full of regulations, data standard guidelines, and creative ways to market. To run a clinical trial now requires up to 40 interconnected systems, hundreds of staff and months of configuration work on inefficient, clumsy systems. We want to build an integrated solution that is so safe, so simple, so efficient that a single doctor with a brilliant idea will be able to bring their innovation to market. We know it is an audacious goal.

We have been safe and profitable with an amazing electronic data capture (EDC) solution for the past 14 years. We don’t want to do that anymore. To meet our audacious goal, we need to transform our product strategy, change our operations, and build an agile and scalable Clincase. Since January 2017, we have built a beautiful and simple clinical supply system. We are now working on an integrated mobile app to collect data directly from patients. At the same time, we are building up our risk based monitoring software, to assist in focusing efforts where they are most needed. Join us – we are 14 passionate health tech enthusiasts, and we are looking for another member of our team.

Who are you?

  • You believe in the impact that technology can have in transforming healthcare
  • You are energized by the idea of contributing to a small and growing company – which involves wearing different hats at times, stepping in to support other teams, and prioritizing competing needs
  • You build strong relationships with others, and want to support them in their endeavors
  • You believe that learning is a lifelong commitment, and have endeavored to develop yourself professionally through education, experience or exposure

What will you do?

The goal of our team is to use our software to help our clients run their clinical trials. We work in pairs of technical experts and project managers to gather business requirements and design solutions. Our biggest challenges are firstly, to balance the customization requests of clients with our vision of a simple and scalable product. Secondly, to advocate for the customer, and project manage a variety of internal stakeholders like product owners, software developers, and designers to facilitate alignment in the project’s vision and ensure timely delivery.

SENIOR ACCOUNT MANAGER

  • Responsible for managing several accounts and being the face of the company to clients – providing clients with excellent service and support
  • Maintain the CRM with all relevant customer/client info and communications
  • Champion and influence for the customer/client at all levels internally
  • Communicate customer/client needs, product related challenges, and opportunities to the product team
  • Be accountable for the revenue stream of accounts by achieving growth targets, preventing attrition, and solving issues that might impact revenue growth
  • Build new business relationships using existing industry contacts
  • Give sales presentations and demos to various types of stakeholders from executive leaders to data managers, business developers, biostatisticians and more
  • Gather and understand market trends that impact how Clincase can serve customers better to form account management strategies

SENIOR PROJECT MANAGER

  • Meet with customers/clients to document and clarify specific requirements of each project
  • Develop comprehensive project plans to be shared with clients as well as other staff members
  • Manage the process of a project from RFP to proposal development, quotation creation, project implementation, wrap up and invoicing
  • Work with software development and product development to translate business requirements to software specifications
  • Work with the product owner and solutions specialists to coordinate deliverables for projects balancing client needs and software development priorities and resources
  • Track project performance, specifically to analyse the successful completion of short and long-term goals – escalating when there are high risk issues that are difficult to solve
  • Use and continually develop leadership and stakeholder management skills internally and externally

What are your qualifications?

  • Fluent in English and German (written and spoken)
  • Bachelor’s Degree in business, life science, information technology or other scientific fields
  • Minimum three years’ experience in project management
  • Minimum three years’ experience in account management
  • Business acumen including financial literacy, familiarity with translating business strategy to actionable plans
  • Strong networker with experience building industry relationships and cultivating them into sales leads

 What do we offer?

A chance to be part of a team oriented, dynamic and learning focused organization.

  • We provide development opportunities to all of our employees
  • We gather together every Monday morning to start the week off with breakfast, and wind down every Friday with beer and pizza together
  • We offer flexible working hours and limited remote office
  • A collaborative and supportive work environment – we are a bunch of people from all over the world that like each other, support each other, and are trying our very best to achieve our audacious goal together.

Clincase offers a competitive salary, benefits package, advancement opportunities and other incentives.

HOW TO APPLY

Please send your CV, presentation letter, salary expectation and earliest starting date in English to info@clincase.com

To learn more about the work we do, please visit us online at www.clincase.com

APPLY 

We are hiring! Technical Writer (m/f)

We are currently seeking a Technical Writer (m/f), able to create, assimilate, and convey technical material consistently and effectively. The perfect Technical Writer for us is methodic, highly skilled in writing, and has a sharp eye for details.

LOCATION

Berlin, Germany

YOUR RESPONSIBILITIES

• Write, edit and proofread technical documentation in English based on the work of our developers and our QA engineers
• Create easy-to-understand tutorials on complex technical information
• Develop effective Standard Operation Procedures
• Concept and implement trainings

YOUR PROFILE

• You have excellent verbal and written communication skills in English (native speaker level)
• You have in-depth knowledge of the clinical research industry legislation
• You are able to read and understand source code in Java and other languages
• You have demonstrated success in writing high-quality technical documentation for developers (APIs, SDKs, etc.)
• You have proven experience with Internet Technologies (REST, HTTP, etc.)
• You are able to work autonomously and are detail-oriented
• German language proficiency is a plus

WHAT WE OFFER

Employees at Clincase are invited to explore new professional opportunities and participate in relevant professional trainings, workshops, and certifications that add value to Clincase. Clincase offers a relaxed working environment in Berlin — the European center of technology, culture and government. Ours is a company culture that encourages open channels for discussion, the free flow of ideas and a real chance to impact, develop and innovate solutions inside a rapidly developing and evolving industry.
We offer a competitive salary, benefits package and other incentives. In addition to an excellent salary there is an allowance for relocation.

HOW TO APPLY

Please apply through the career link below with your CV, cover letter, salary expectations, and earliest possible starting date. Should you have any questions, you can send an email at info@clincase.com To learn more about the work we do, please visit us online at www.clincase.com.

APPLY

GUF-CDISC Event on the 4th Oct 2016

Quadratek Data Solutions participated the GUF-CDISC Event (Le Groupe des Utilisaturs Francophones des standards CDISC) in Rennes, France, the industry’s premier clinical trial technology gathering in Rennes on the 4th of October.

Henning Lux, CEO of Quadratek Data Solutions addressed the title ‘From eCRF to SDTM – why is it still hard for many organisations?’

The CDISC standards have been widely applied in the past years among major stakeholders in the clinical field. It improved the data transfer process by providing better tools. Yet, transforming data from eCRF to SDTM is in many cases a manual and laborious process for each separate trial.

Why are many eCRFs still implemented without considering CDISC standards? What could be done to further automate data transformation to SDTM? Will we ever get to create SDTM from the eCRF with a click of a button? What are the current and future obstacles of further standardisation? With this opportunity, we discussed the questions above and shared our real life examples that many organisations are experiencing.

Brazilian festival at the office

We had a delightful São João party, Festa Junina at the office. It has originated by celebrating St. John the Baptist and currently it’s one of the biggest festivals in Brazil.

Our Brazilian colleagues prepared some traditional food and drinks from Brazil. They were as delicious as it sounds so exotic! We had Cachorro quente (hot dogs), pacoca, pipoca (popcorn), brigadeiro, pe de moleque, quentao, pao de queijo, guarana antartica and so much more! We also decorated the office together. The flags are called bandeirinhas and it’s a traditional element for São João.

We, Clincase, value our intercultural atmosphere and try to cultivate more encouraging attitude to learn each other’s culture and background.

Stay tuned for our next multi-culti event!

Singapore officials visit Clincase

Last Friday, we had some special guests from Singapore to our Berlin office. As Berlin is a popular place for Startups and Tech companies, the city is attracting the world attention to look for new business opportunities. Hence, the government officials from Singapore want to learn the Berlin’s vibrant Tech & Startup scene.

The National Population and Talent Division, Ministry of Manpower, Ministry of Trade and industry, and Strategic Planning & Futures, Prime Minister’s Office of the Singapore visited our office to encounter our business experience and intercultural atmosphere.

We had great time getting to know each other and learn from different business experiences. We are excited to have these opportunities to connect diverse organizations all around the globe.

Clincase received the CIR accreditation

We, Quadratek Data Solutions, are happy to inform you that we’ve received CIR accreditation from the French Ministry of Higher Education and Research since 2015 for the next three years.

The Research Tax Credit (‘Crédit d’Impôt Recherche’, CIR) gives qualified research-based European companies, who are subject to corporate tax in France, the ability to claim tax relief on costs of R&D activities.

This means that Quadratek Data Solutions is considered as an innovative and approved provider of research services for companies based in France. With this accreditation, our current and prospect customers in France can receive a tax relief of their R&D expenditure.

You can find our name on their list and read further about CIR here. www.enseignementsup-recherche.gouv.fr

Settling in at our new office space

Since last year, there has seen some big changes for Clincase, one of them being moving to our new office to accommodate our growing team. We are settling in nicely to our cozy new space.

Already having the new staff come on board, this means that we are able to keep up with demand of our customers and to ensure we give the best service possible. We continue to thrive for our rigid quality with an increase in experience. So stay tuned as we continue our expansion!

Meet our V&V manager Rafael!

We are happy to present our Verification & Validation manager, Rafael. As he wants to share his knowledge and experience in verification and validation of software development, we’d interview him about his vision and passion at Quadratek Data Solutions and Clincase. Here he explains how, through the V&V process, he wants to deliver a well-crafted product for our customers.

 

– Could you explain your role at Qaudratek Data Solutions?

Rafael: My role is to develop and implement standardized procedures and policies for verifying and validating software in a highly regulated industry like the one we are in. My main focus is to improve Software Development Life Cycle (SDLC) process in accordance with Agile methodologies like Scrum, Kanban, SAFe, and TIR 45, which is particularly used in medical device software development.

 

In other words, my role is to develop, implement, and execute certain strategies on how we can improve our process in order to fulfill our customer demand. I must ensure that all development projects are following the defined development process by testing features and reporting the results during and the development cycle not only at the end.

 

– What’s your experience in V&V?

Rafael: I’ve been working for 11 years in software development while executing different roles such as Software engineer, Product Owner, Scrum master, Software development process engineer, and Software development leader. I have sufficient knowledge in Agile and coached software development team and Product Owners in the methodologies mentioned above which strengthened my skills in people management.

 

Working as Software development process engineer has equipped me with certain knowledge like software requirements modeling, code design, developing, testing and automated testing, verification and validation. With my previous work experience I am confident in the Java Enterprise platform and its surrounding technologies like Hibernate, EJB, Struts, jBoss, Tomcat, Spring, JSP, Ajax, Java Script and so on. I am certified in Certified Scrum Master (CSM), Certified Scrum Product Owner (CSPO), Certified Scrum Developer (CSD), SAFe Practitioner, Sun Certified Web Component Developer (SCWCD), Sun Certified Java Programmer (SCJP) and Oracle Certified Associate (OCA).

 

– Could you explain what Verification and Validation in software development is?

Rafael: Every software development process should ensure customer needs and expectation to be fulfilled. This is Software Validation, which means that you built the right thing. If the software is coded under the right system requirements, this is called Software Verification, which means you built it right. Our aim at Clincase is to fulfill customer expectation, not only at the end of the process but also during the process. Developing software in regulated industries, like the pharmaceutical industry, Software Verification and Validation are even more important than usual. In short, the goal of V&V is to ensure we deliver customers a well-crafted software.

 

In details, good practiced activities in V&V should include maintaining traceability of requirements, test cases and its results, and updating the entire software documentation such as user manuals, release notes, software requirements. And it includes performing system testing like regression, user acceptance, integration tests during the process, after each sprint, and before the release

 

– Then what does Verification and Validation mean to you??

Rafael: In my point of view, the quality of a product is directly connected to the quality of its process. Whether we are or not in a regulated environment, we should focus on continuous improvement of our process, always aiming to delivery better software solutions with high quality standards that fulfill user needs.

 

– Lastly, how do plan your future at Clincase and QDS?

Rafael: I hope to contribute my knowledge in agile methodologies, Software Development Life Cycle, and people management for improving our process to be more efficient and effective in order to delivery our customers the well-crafted software, Clincase. Overall my aim is to improve quality of the software development process. In order to do so, I must work with my team. I need to gather inputs from our team who actually operate the process and are the best ones who can give me valuable ideas how to improve its process.

 

Introducing our Quality Assurance Manager

We, QDS and Clincase, are happy to introduce our Quality Assurance Manager, Secil. Here is her talk about her motives and vision at Clincase.

 

-What do you do at Clincase? 

Secil:  As the Quality Assurance Manager, my role is to ensure to implement the Quality Management System, encompassing all aspects in the company, as a part of the daily routines. Nowadays, we are highly focused on the controlled documents aligning with the processes and industry regulations.

In addition, we are working in collaboration with the department Quality Assurance Representatives in order to ensure all functions in the company have sufficient qualification for conducting their tasks. Hence, we’ve improved our training process accordingly and planned several trainings related to quality and technical awareness. We realize that we could only achieve the maximized quality when involvement of the qualified team is fully devoted to our quality policy and continuous process improvement.

 

-What’s your background in Quality Assurance?

Secil: I have 7 years of background in quality assurance particularly related to ISO9001, Lean manufacturing systems and problem solving techniques. Before joining the QDS team, I was working in a global company and my role was to implement and train employees with the related production systems in the shop floor such as ISO9001, Lean Administration and Total Productive Maintenance (TPM) including 5S, Autonomous Maintenance, Poka Yoke and Project Management. During the implementation phase, we used several problem solving methodologies such as the 6 Sigma, Kobetsu Kaizen and Figure 8 methods.

 

-Then what does it mean to have the Quality Management System for Quadratek Data Solutions?

Secil: QDS is an important Electronic Data Capture (EDC) system provider in a highly regulated industry and thereby must comply with the related regulations and laws. Accordingly, QDS has a high focus on the quality and maintains the Quality Management System effectively since 2004.

 

-What does the Quality Assurance personally mean to you?

Secil: As you know, everybody in the organisation has different roles in order to contribute to its services and maintain the entire organisation. For me, the role of the Quality Assurance Department should be gathering all these different roles in a commonly shared quality perspective and drive the team to its defined vision. Of course this could be only possible when everyone in the team participates and accepts the quality as a part of daily life.

 

– How can you contribute to QDS and Clincase, do you have plans for the future?

Secil: In the short term, our plan is to improve Corrective Action & Preventive Action (CAPA) process flow for internal topics as well as the audit feedbacks in order to have a systematic methodology to be able to see all items in a single common system. Also, we would like to increase the role of quality in the main processes by involving the development steps with the planned risk analysis and the design reviews in coordination with the Validation & Verification Manager.

 

Get in Touch