Company: inVentiv Health Clinical
Closing Date: 28 Feb 17
Salary (£): Negotiable
inVentiv Health – Transforming Promising Ideas into Commercial RealityJob Title:14457 Senior Analyst, Information Technology (Applications), EMEAIn Person participation: The person is expected to work in German time zone (CET) and occasionally be able to attend business meetings in Berlin. During the initial onboarding process, the person should be able to visit the Berlin site for a longer period of time (e.g. 2 – 4 weeks). ...
inVentiv Health – Transforming Promising Ideas into Commercial Reality
14457 Senior Analyst, Information Technology (Applications), EMEA
In Person participation: The person is expected to work in German time zone (CET) and occasionally be able to attend business meetings in Berlin. During the initial onboarding process, the person should be able to visit the Berlin site for a longer period of time (e.g. 2 – 4 weeks). Additionally, the person should be able to attend online meetings with US East Coast morning times.
* Change request creation, analysis of the change, risk assessment, contribute to project and change implementation. Creation of deliverables and document management (setup workflows, upload documents, actively keeping track of workflow completions, being able to communicate to involved stakeholders in case of delays …).
* Analyzing internal user feedback or update releases from vendors doing the analysis based on internal process what is an applicable change and working on next steps to initiate and complete change request.
* Support with authoring of CSV relevant documentations, such as user requirement specification, validation plan, test scripts and test reports.
* Interact with business application leads, Process Owner Representatives and System Owners/Application Managers and participate in Clinical Information Technology projects.
* Provide technical and business user expertise for clinical processes such as:
* clinical data management & coding (MedDRA, WHO-DD), (mandatory),
* randomization and statistical analysis (mandatory),
* clinical data acquisition, (preferable)
* clinical data review and visualization methods (preferable) .
* Several years of IT application business analysis experience, preferably Pharma or Healthcare related
* Several years of experiences with profound knowledge and understanding of Computerized System Validation according to GAMP 5 within the GxP environment
* Several years of experience in clinical trials related area, data management and electronic data capture experience, medical coding, randomization and statistical analysis is preferred
* IT application implementation and change management experience is preferred
* Strong IT acumen, technical background and knowledge of system validation, migration and related system documentation principles is preferred
* Technical Knowledge and Understanding of Clinical Data Warehouses, EDC systems, Statistical Analysis programming environments/requirements is preferred
* Strong Communication Skills
* Excellent English skills both written and spoken
In return we will offer:
* Competitive remuneration package with excellent benefits
* Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
* Opportunity to work within a successful and rewarding environment.
Location: EMEA, home or office based.
We look forward to receiving your application.
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment. For more information, visit inVentivHealth.com.
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