Clinical Document Manager

RM IT Services GmbH


Job ID :

15866


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

clinical Trial Master File process


Salary :

Negotiable


Date Posted :

06 Oct, 2020



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Pharma Business Development Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

100.00%





Description

Clinical Document Manager Vacancy for a globally operating Basel based company in the pharmaceutical sector.

Your experience/skills:

* 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

Your tasks:

* 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 lifecycle management through close collaboration with system support and business functions

Start:
Duration:
Location:
Ref.Nr.:11/2020
12MM+
Basel, Switzerland
BH16090

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.


Company Name:

RM IT Services GmbH


Headquarters:

Hackescher Markt 2-3,


Sector:

Staffing Firms


Country:

Germany


Zipcode:

10178


Website:

www.rmgroup.ch


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


Phone No. :

+41583560693


Professional Resources, Professional Services Since its establishment in 1998, the RM Group has developed to become one of the leading companies in the field of IT Resources Management in Switzerland. As a specialised recruitment agency, we find highly qualified experts for your projects. This is the basic requisite for the targeted development of IT strategies and for the practical implementation of IT projects. The RM Group is among the few significant Swiss recruitment agencies which fulfills all requirements related to compliance and quality assurance per ISO 9001, ISO 14001, GoodPriv@cy® and EcoVadis certification.

For more information,visit www.rmgroup.ch.

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