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Senior Clinical Outsourcing Compliance Manager, Ballerup

LEO Pharma A/S


Application deadline:8-Dec-2022
Location:Ballerup2750,,Denmark
Contract type:Permanent
Job ID:526

Do you want to be part of an exciting environment?

Do you have a passion for clinical development and compliance and want to put your extensive GCP knowledge into play to develop efficient and compliant sponsor oversight processes and tools? Do you thrive working globally with many stakeholders in a fast-paced 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 improve the quality of life for millions of patients worldwide. To succeed, we invest massively in Research & Development, constantly demanding a strong and continued focus on driving efficiencies and optimizations in our organization, and that is why we need you!

If you are an experienced sponsor oversight lead, compliance specialist, trial manager, or QA specialist with profound knowledge of clinical development and GCP and looking for a job, where you can unfold all your skills in a role with significant impact and influence, you are the perfect match!

About the job - drive operational excellence in sponsor oversight
As Senior Clinical Outsourcing Compliance Manager, your overall objective is to support the operational excellence in Global Clinical Operations and Medical Sciences by developing outsourcing processes and tools concerning sponsor oversight in close collaboration with our global CRO vendor, global QA, Clinical Procurement, and the trial teams. In this role, you will be key in bridging between the CRO, QA audits, and trial teams ensuring the right level of oversight is applied, implemented, and communicated. You will be the owner of the global operational oversight framework and ensure our processes are GCP compliant, while supporting a flexible and agile working environment with digitalization and outsourcing on the agenda.

Your primary tasks will be to:

• Being the subject matter expert within sponsor oversight

• Drive the development and implementation of sponsor oversight processes and tools

• Provide training, advice and drive best practices and knowledge sharing on CRO collaboration and sponsor oversight processes and tools

• Collaborate with the CRO counterpart on mutual collaboration framework and metrics

• Drive quality and risk assessments in relation to CRO collaborations

• Collect input and learnings to monitor the CRO collaboration and quality performance

• Attend CRO governance meetings addressing quality performance and mutual collaboration framework

• Provide input to Global Quality Audits for the audit risk assessment scheduling tool on the CRO collaboration

• Act as internal auditee on CRO audits and follow-up on audit CAPAs

• Drive operational excellence in sponsor oversight through continuous stakeholder management and communication

• Drive or support ad hoc compliance initiatives related to clinical development processes

About you - experienced within clinical development
You have a master in natural or life science like Pharmacy or equivalent education. In addition, you have at least five years of hands-on working experience within the clinical drug development discipline and a solid knowledge of GCP and related regulations. Experience in clinical quality assurance, clinical trial processes, sponsor oversight, or GCP auditing is required. Further, you demonstrate solid experience in driving and implementing process optimizations within R&D in the pharmaceutical industry.

To succeed in the job, you use your self-motivation, impact and pro-active can-do attitude to achieve long-lasting results, secure end-to-end thinking and are an excellent collaborator with a supportive mindset. You are organized, detail-oriented, and quality conscious without losing the big picture. You easily build relationships across the organization and with the CRO and benefit from your excellent communication skills that enable you to communicate your messages in an easily understandable way, written and spoken. You are a team player focusing on developing an excellent sponsor oversight framework within the organization and in collaboration with the CRO and are, at the same time, comfortable with taking ownership and working highly independently.

Being part of a constantly developing organization, you must enjoy and embrace an environment of change and take a pragmatic approach to problem-solving.

About Clinical Process Management - your new department
The position is anchored in Clinical Process Management, which is one of two 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 ten 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 and optimisations are part of everything we do.

We look forward to receiving your application before 8-Dec-2022. However, we will be screening and interviewing on an ongoing basis during the application period.

For more information, please contact Trine Danø Klingberg, Head of Clinical Process Management, on +45 3126 2553.

Let's pioneer together
At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what's possible for each other, our company, and our patients.

At LEO Pharma, we welcome and consider applications from all qualified candidates because we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions for LEO Pharma and meet the needs of the wonderfully diverse marketplace we operate in.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

Created
08/11/2022

Reference
526

Category
Pharmaceutical

Job type
Full Time

Country
Denmark

City
Ballerup

Zip
2750

Salary
Competitive



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LEO Pharma A/S - hurtigt overblik


LEO Pharma A/S
LEO Pharma A/S
LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally.

Placering
Industriparken 55
2750 Ballerup
Logo: LEO Pharma A/S
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