Beschreibung
Document Manager vacancy for a globally operating Basel based company in the pharmaceutical sector.Your experience/skills:
- 4+ years of work experience in clinical development/clinical operations plus a minimum of 2 years of experience experience with document management systems and excellent understanding of system structures and generic document management functionality
- A thorough understanding of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
- Expertise in clinical documentation and reporting combined with a solid knowledge of technical processes and PC environment including Microsoft suite
- Familiarity with the national and international data protection legislation paired with competent handling of project work or project management in a global, cross-functional multicultural and international matrix organisation
- University degree in life science, healthcare or equivalent
- Languages: English, fluent in written and spoken, German is beneficial
Your tasks:
- Aiding with the definition and refinement of the document management strategy for Clinical Documentation relevant for Regulatory Submission, such as Clinical Trial Protocols and Clinical Study Reports
- Designing and overseeing the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area as well as managing the system and process Implementation in collaboration with Business and IT Functions
- Orchestrating business requirements across NVS and identify achievable business benefits in combination with coordinating system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected
- Contributing to the design of training concepts and material while also providing input to technical teams for migration and supporting migration testing
- Planning and overseeing rollout and change management activities plus ensuring deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
- Acting as Business Administrator in the electronic Document Management System ensuring appropriate user access restriction, accurate and compliant document creation and document lifecycle management in close collaboration with system support and business functions
Start:
Duration:
Location:
Ref.Nr.:
09MM+
Basel, Switzerland
BH16462
Does this spark your interest? Then take the next step by sending us your CV as a Word document and a contact telephone number on which you are reachable during working hours.
Going the Extra Mile.
As a preferred recruitment agency for Swiss banks, international insurances, finance service providers, software and pharma companies, we acquire exciting positions since 1998 in Zurich, Bern, Basel and other regions in Switzerland every day.
Due to work permit restrictions we unfortunately can only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
New to Switzerland? In case of a successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health- and social insurance
- Work permit and much more
Thank you for your interest. By applying, you give us the permission to internally store and process your data for the application process. We strictly comply with the applicable data protection laws.