Business Systems Manager – clinical trial management, Ferring / 1739
Ferring Pharmaceuticals is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. At Ferring International PharmaScience Center (IPC) in Copenhagen they are nearly 600 people, primarily scientists and specialists breaking new ground to help people live better lives all around the globe. They focus their R&D efforts on peptide-based drugs and biotechnology derived medicines.
As a privately-owned company Ferring benefit from the privilege to think and work with a long-term horizon. You will experience the same freedom in your search for new solutions. Your desire to innovate and explore will contribute to fulfilling Ferring’s ambition of becoming the world’s leading company within reproductive medicine and maternal health. If you need help, you will find it. If you want challenges, they are right in front of you. If you are looking for freedom to find your own way, you are trusted to do so. If you want to make a mark in the world for the better, you feel just like the rest of your colleague. Read more at ferring.com
Global Clinical Compliance – your new team
You will join 9 skilled and dedicated compliance specialists. They are responsible for the processes and systems used in the global clinical domain across Ferring and manage the clinical trial management system including the eTMF. Additionally, they facilitate compliance during clinical trial life cycle by maintaining the areas SOPs and being responsible for public disclosure of clinical trials. They are part of the Global Clinical Department and work in a global setting with colleagues in the US, Japan and China.
Business Systems Manager – clinical trial management
Do you want to drive change and have influence in a rapidly changing, global organisation?
Do you bring solid experience from working with GxP IT systems in the pharma business? Are you at the same time looking for an opportunity to bring all of your skills into play in a role where your knowledge and ideas are just as appreciated as expected? If so, you now have the chance to influence their future way of handling their new clinical trial management system, Veeva Vault – how they work with Vault Clinical and secure on-going optimisations. You can look forward to being part of an organisation that believes good ideas need room and nourishment to flourish.
System expert and link between end users and IT
Basically, your focus as Business Systems Manager is to help your colleagues across the global organisation to “work smarter, not harder” and in compliance with the overall GxP framework. You are the link between their customers in various business lines and IT. Based on you thorough understanding of the Veeva Vault Clinical functionality, you provide advice to primarily super users around the globe and ensure inspection readiness. However, as you will enter just before they go live with Veeva Vault, you must expect more questions and confusion than in times with a full running system. So, if you do not already know Veeva Vault, you must be able to learn fast. Your primary tasks include to:
- Build thorough understanding of Veeva Vault – the clinical part of the system
- Shape the landscape on how they work with Vault Clinical and optimize this way of working
- Provide system support and training in line-of-business
- Trouble-shoot/incident handling on issues reported by their users
- Review and manage system access requests
- Maintain system documentation
- Participate in system maintenance and development projects, i.e. configuration changes, test and validation activities
- Ensure inspection readiness in collaboration with the team
A vital part of your road to success will be founded on your ability to develop a good and constructive collaboration with the key stakeholders both in Line of Business (in particular Global Clinical Operations) and IT – with clinical operations support on setting up trials and ensure data quality as the most prominent. You will need to follow the pace of the clinical trials, and maybe even be in front now and then. As part of a service unit it is naturally just as important that the end-users experience you as forthcoming and solution oriented.
Your new workplace is Ferring IPC in the Ørestad part of Copenhagen. However, later in 2021 you will unfold your skills in their spectacular and state-of-the-art new domicile “SoundPort”, a future landmark located next to “Den Blå Planet”, near Copenhagen Airport. You will refer to the Director of Global Clinical Compliance,
5+ years’ experience from working with GxP IT systems
They are looking for someone, who is motivated by driving changes. This calls for your curiosity as well as your good communication skills and your ability to explain why, how and who. Additionally, you must thrive in an environment where changes are being introduced and not everything is clearly defined – you will be trusted to find the right way forward. As you serve a global organisation covering multiple skillsets and cultures, you must bring an open mind and the ability to think out of the box and find solutions to new and unknown challenges. Additionally, your CV comprises:
- A university degree in life science or IT
- 5+ years’ experience from working with GxP IT systems, preferably clinical
- Motivation for becoming Veeva Vault expert – maybe already some knowledge of the system
- Good English skills, written and spoken
Best Talent is responsible for the recruitment for this position at Ferring and review your application on a confidential basis. Forward your application including your CV attention “1739/BSM” by way of e-mail to firstname.lastname@example.org You can read more about Best Talent at www.besttalent.dk.