Doc Manager- TMF - Big Pharma!
I am looking to speak with TMF professionals interested to work in Basel on a contract for 12 months- with the option of extension too. We have a position currently for two TMF Focused roles with a focus on CDMS. This is a fantastic opportunity for someone who is looking to join a Huge Pharmaceutical name and gain reputable experience, which will open career doors for you moving forward. It will be based in the companies global HQ in Basel. So also an option to gain international experience, if you are not already based here.
Be responsible for efficient and appropriate management of GxP relevant clinical documents from creation through archival in compliance with applicable internal and external requirements for a defined business process area or project. Scope of this profile applies to Clinical Documents relevant for Regulatory Submissions.
1. Support the definition and refinement of the document management strategy for Clinical Documentation relevant for Regulatory Submission, such as Clinical Trial Protocols, Clinical Study Reports, etc.
2. Design and/or oversee the process, system and tool landscape that supports the management GCP relevant documentation within a defined business process area. Manage system and/or process Implementation in collaboration with Business and IT Functions.
3. Act as Business Analyst/Lead to manage the implementation of Document Management Related
o Coordinate and participate in system testing activities such as User Acceptance and Performance Qualification Testing to ensure business benefits are reflected
o Support the design of training concept(s) and training material
a. Provide input to technical teams for migration and support migration testing
b. Plan, prepare and oversee rollout and change management activities (communication and training)
4. Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs
5. May act 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.
The above responsibilities are to a large extent based on interdisciplinary topics and re-quire the employee to liaise, cooperate with and coordinate numerous related functions such as internal Clinical Operations functions, CRO representatives, IT.
Education: Minimum Bachelor's degree in life science/healthcare or equivalent
Languages: Fluent English (oral and written), German of advantage
o Thorough knowledge of clinical Trial Master File process, regulatory requirements and Good Clinical Practice, in particular for outsourced TMF filing activities
o At least 4 years in clinical development/clinical operations
o At least 2 years working experience with document management systems and excellent understanding of system structures and generic document management functionality
o Advanced knowledge of clinical documentation and reporting
o Good understanding of technical processes and PC environment including Microsoft suite of products
o Knowledge of the national and international data protection legislation
o Advanced ability to work independently
o Experience with project work or project management in a global, cross-functional multicultural and international matrix organisation
o Excellent communication, organization and tracking skills
Call me Daniel Watson at NonStop Recruitment now for a confidential conversation. Contact me on D.Watson@nonstop-recruitment.com or +41 435 080 817, please send your CV in word format OR if this does not sound like the opportunity for you, but you are a clinical research professional within the pharmaceutical, medical device or biotech industry, please feel free to get in touch, to see other opportunities we may have within this field.
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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