For our client, an international pharmaceutical company Basel, we are in search for a TMF Manager Outsourced Studies for a 2-year contract starting ASAP.
What the company offers you:
You will be responsible for efficient and appropriate management of Trial Master Files and other TMF related, inspection-relevant documents for studies with an operational model of outsourced and/or other third party TMFs
International environment
Competitve salary
Contract for 2 years with a possibility of extension
Your responsibilities:
Supporting the definition and refinement of the document management strategy for outsourced TMFs, including TMF sponsor oversight activities
Promoting best documentation practice to line functions and provide guidance on document standards for the business functions to support inspection readiness and adherence to Good Documentation Practice
Ensuring deliverables comply with HA guidelines, GCP and internal SOPs
Providing input to technical teams for TMF migration, conduct migration testing in particular for TMF sections previously outsourced to CROs
Planning, preparing and overseeing rollout and change management activities (communication and training)
Acting as Business Administrator in the electronic Document Management System (eDMS) ensuring appropriate user access restriction, accurate &compliant document creation and document lifecycle management in close collaboration with system support and business functions
Your profile:
Minimum Bachelor’s Degree in Life Science/Healthcare or equivalent
Thorough knowledge of clinical TMF process, regulatory requirements and GCP, in particular for outsourced TMF filing activities
At least 5 years in clinical development/clinical operations
At least 3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
Good understanding of technical processes and PC environment including Microsoft suite of products
Knowledge of the national and international data protection legislation
Fluent English (oral and written), German of advantage
Welcome to nemensis!
We look forward to getting to know me!online bewerben
Ihr direkter Kontakt:
Marcel Honegger Kägenstrasse 18 4153 Reinach Jetzt per E-Mail oder telefonisch bewerben
Tel.: +41 61 205 98 78 E-Mail: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!
