We are hiring! Logistic Support Analyst (M/F)

Company Overview

Clincase is a software development company that has developed a software for electronic data capture in clinical trials. We provide innovative, e-Clinical Technology Solutions to contract research organizations (CROs), scientific and academic research institutions and pharmaceutical companies around the world. We believe in working together to create opportunities and invite qualified, enthusiastic professionals with experience in clinical trials and in the life science industries, or with interest and backgrounds in regulatory environments to apply for one of several roles currently available in our Berlin offices.

About The Role

Job Type: Full-time

You will work with the Clincase team to maintain inventory with accuracy and foster a good working relationship and to better serve our customer needs.

Duties & Responsibilities

  • Buy, install, pack mobile devices and fulfill orders in an efficient and accurate manner
  • Send regular shipments from the Distribution Center in a timely fashion
  • Conduct routine audits of inventory levels to maintain highest levels of accuracy
  • Maintain an excellent working relationship with our Expert team and work to support them to make sure deliver excellent experiences for our customers
  • Solve delivery problems with good manners
  • Serve customer needs as a 1st line hardware technical support

About You

  • Thrives in a fast pace work environment that has you constantly on the go. Works well under pressure
  • Self-motivated, resourceful, proactive and offer help and support wherever needed
  • Can organize tasks in line with company priorities and complete them efficiently and on time
  • Have good technical skills, adore mobile gadgets, able to setup and configure any mobile device on a basic level.

Requirements

  • Prior experience in back-of-house, warehouse, or delivery environments preferable
  • Impeccable attendance, punctuality, and time management
  • Some experience with ERP software is preferred

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.

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.

 

Clincase had Team Workshop for 2016

The QDS & Clincase Workshop was held on the 15th of January in Berlin. Our focus for 2016 is to enhance overall customer satisfaction. As the team is growing bigger and with it more enthusiasm, this workshop aims how we can move forward as a productive team in order to deliver the best EDC product and service.

Mr. Henning, CEO, started the day by delivering a keynote speech, then followed by presentations from the head of each department. Everyone actively shared their perspective and contributed with various ideas on how we can fulfil our customers’ satisfaction in the innovative clinical trial industry.

We are looking forward to another year full of interesting challenges and success.

The 2016 QDS Kick Off

Clincase Takes a Place at the 2016 DIA Euro Meeting in Hamburg

Clincase and QDS are pleased to announce our attendance at the 28th Annual EuroMeeting of DIA which will be held from April 6th-8th in Hamburg, Germany. The theme of this year’s meeting is “Innovation – Do you Win by Being IN? Or, What is the Genuine Benefit of Innovation and Can It Be Challenged?” We are looking forward to contributing our perspectives and voice to that discussion and to meeting and greeting fellow participants.

We invite you to stop by our booth in the main exhibition hall of the Conference Center Hamburg at station N4 to learn more about what you think of innovations in the EDC and e-Clinical Technology solutions market and to tell you more about us and what we do.

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