Technical Lead eTMF/DMS für Pharmaindustrie

Vor Ort
4 Monate (Verlängerung möglich)
Harvey Nash (Schweiz)
Schweiz (BASEL)
flag_no Schweiz

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On behalf of one major client in the Pharma industry, Harvey Nash is currently looking for an IT architect / Lead architect for a project focused on eTMF (electronic Trial Master File) in Switzerland.

Project description
•Evaluation of customer, competitive and in-house systems for technical/commercial points of view.
•Advise users on IT concepts and solutions
•Review and audit of informatic projects.
•Creation and assessment of studies and concepts for implememtation in informatics taking into account current and future business needs.
Special Requirements

•Ability to perform a role of a Lead Architect combined with Functional Analyst role
•Deep knowledge of Document Management Systems, Functionality and Architecture, preferably Documentum and Sharepoint-based solutions
•Ability to derive requirements from analysis of business drivers, objectives and business analysis stream's output
•Ability to consult and influence requirements and functional designs using profound DMS best practices.
•Background in pharmaceutical area, Clinical Operations or Regulatory; ideally in eTMF (electronic Trial Master File) or Dossier Submission related area
•Collaborate with Architects from other areas (Infrastructure, related solution teams, Software Architects, Enterprise Architects) to understand standards, dependencies and impacts.
•Track record to lead a software selection process, including management of selection criteria
•Knowledge of collaboration concepts and solutions required
•Ability to contribute to project planning
•Experience to work in validated environments, GxP and 21 CFR part 11

Interested? Then please send your complete CV (word documents preferred) to or contact me directly under I am loooking forward to receiving your application