TMF Manager Outsourced Studies

RM IT Services GmbH

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :

Bachelor of Business Administration

Address 1 :

Western Europe,Switzerland,Basel-Country,

Key Skills :

TMF Manager Outsourced Studies

Salary :

Market Rates

Date Posted :

12 Oct, 2021

Company Name :

RM IT Services GmbH

Location1 :


Job Category :

Clinical Research Jobs

Experience :


Job Type:


Travel Amount:



TMF Manager Outsourced Studies vacancy for a globally operating Basel based company in the pharmaceutical sector.
Your experience/skills:

* 3+ years working experience with document management systems and excellent understanding of system structures and generic document management functionality
* 5+ years of experience in clinical development or clinical operations as well as advanced knowledge of clinical documentation and reporting
* Thorough understanding of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
* Ability to understand technical processes and PC environment including Microsoft suite of products as well as good knowledge of the national and international data protection legislation
* Experience with project work or project management in a global, cross-functional multicultural and international matrix organization
* University degree in Life Science/Healthcare in a relevant field
* Languages: English, fluent in written and spoken, German of advantage

Your tasks:

* Supporting the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities
* Overseeing the process, system and tool landscape that supports the management of outsourced TMFs.
* Promoting best documentation practice to line functions and providing guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice
* Ensuring deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
* Acting as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate and compliant document creation and document lifecycle management
* Leading improvement and innovation initiatives in a matrix organization
* Acting as Business Lead to manage the implementation of a Next Generation DMS in close alignment with IT and business functions

Start: 11/2021
Duration: 10MM+
Location: Basel, Switzerland
Ref.Nr.: BH17629
Does this spark your interest? Then take the next step by sending us your CV 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


Hackescher Markt 2-3,


Staffing Firms







100 - 499


Pharmaceutical Recruitment

Phone No. :


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.

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