Clinical Document Manager
Posted on Oct 8, 2020 by RM IT Professional Resources AG
Clinical Document Manager Vacancy for a globally operating Basel based company in the pharmaceutical sector.
- Several years of work experience with project work or project management in a global, cross-functional multicultural organization
- 4+ years working experience in clinical development and operations dealing with document management systems
- Excellent knowledge of clinical documentation and reporting, understanding of system structures and generic document management functionality
- Expertise in clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
- Competent handling national and international data protection legislation as well as good command of technical processes and PC environment including Microsoft Suite products
- Ability to work independently as well as in team through excellent communication, organization and tracking skills
- Minimum Bachelor's degree in life sciences, healthcare area or equivalent would be favourable
- Languages: English, fluent in written and spoken, German is advantageous
- Supporting 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
- Creating and observing the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area
- Managing the implementation of Document Management Related Applications by performing Business Analyst/Lead tasks
- Coordinating business requirements across the company and identifying achievable business benefits
- Arranging and supporting system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected
- Ensuring deliverables comply with Hospital Authority guidelines, GOP and internal SOPs
- Establishing appropriate user access restriction, document creation and life cycle management through close collaboration with system support and business functions
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.