Experienced Trial Master File Process Specialist
Do you want make a difference?
Do you have a high-quality mindset and want to put your robust knowledge of eTMF management into play to develop efficient TMF processes and measures? Do you thrive working globally with many stakeholders in an innovative company? Then this job might be something for you.
LEO Pharma has set the ambitious goal to become the world’s preferred dermatology care partner and to improve the quality of life for millions of patients around the world. To succeed, we invest massively in Research & Development and our pipeline and clinical activities are growing rapidly, constantly demanding a strong and continued focus on driving efficiencies and optimisations in our organisation, and that is why we need you!
If you are an experienced eTMF Management Specialist with solid knowledge of GCP and clinical trial methodology, and are looking for a job where you can unfold all your skills in a global role with significant impact and influence in a fast paced environment, you are the perfect match!
About the job – efficient and high-quality eTMF management processes
As our TMF Process Specialist, your overall objective is to drive eTMF operational excellence in Global Clinical Operations and Medical Sciences by development of compliant, high-quality and efficient eTMF management processes in collaboration with key stakeholders across the organisation. In this role you will be pivotal in ensuring that our eTMF processes are following internal and external requirements, regardless if it is an in-house or outsourced clinical trial, and that the eTMF processes at the same time support an agile working environment with digitalisation of clinical trials on the agenda.
Your primary tasks will be to:
Being the subject matter expert within eTMF management processes, governance and filing requirements, while ensuring compliance to regulatory requirements and other guidance’s applicable to management of clinical documentation
Drive eTMF operational excellence through continuous stakeholder management and communication
Be responsible for ensuring adequate and compliant eTMF QMS documents such as SOPs, WI’s and TMF Management Plan template
Outline eTMF strategies, processes and measures for vendor handling of eTMFs for outsourced trials
Drive and identify opportunities for continuous improvement of eTMF processes in close collaboration with key stakeholders across the organization
Develop guiding eTMF reports, tools and measures to support audit and inspection ready eTMFs
Pro-actively develop, lead and organize eTMF training as well as lesson’s learned & best practice sharing to ensure robust knowledge and awareness of eTMF filing requirements
Provide eTMF filling guidance to end-users upon request
Participate in eTMF audit and inspections as the eTMF process SME
Engage in dialogue with eTMF vendor on future system enhancements and assess changes to be implemented
We are offering a job with considerable individual responsibility and challenges, and a high level of visibility, as you will collaborate with a great number of stakeholders across the Global Clinical Operations and Medical Science’s organization.
About you – an experienced compliance specialist
You have a bachelor/master in natural science, information science or other equivalent relevant education. Ideally, you have at least five years’ hands-on working experience within the clinical drug development discipline and a solid knowledge of current GCP and related regulations. Additionally, you demonstrate solid experience with eTMF management processes and preferably the Veeva Vault eTMF software. You have experience in driving and implementing process optimizations within R&D in the pharmaceutical industry.
To succeed in the job, you use your personal impact and pro-active can-do attitude to achieve long-lasting results. You recognise the importance of building relationships across the organization and benefit from your excellent communication skills that enable you to bring your messages across in an easily understandable way, written and spoken. You are an excellent collaborator with a supportive mindset, and you describe yourself as structured, organized, detail-oriented, and quality conscious without losing the big picture.
Becoming part of an organization constantly developing, you must enjoy and embrace an environment of change and take a pragmatic approach to problem-solving.
About Clinical Process Management – your new department
Clinical Process Management is one of four departments in Clinical Operations Support within Global Clinical Operations. We strive to support our internal stakeholders with processes, training, and compliance to deliver high-quality clinical trials. The department consist of nine dedicated process and compliance specialists with high professional standards. The working atmosphere is busy, collegial, and informal, and as for the rest of LEO Pharma, innovation is part of everything we do.
We look forward to receiving your application and we will be screening and interviewing on an on-going basis.
For more information, please contact Irene Rasmussen, Director of Clinical Operations Support, on +45 4137 1109 or Trine Danø Klingberg, Head of Clinical Process Management, on +45 3126 2553.
