Clinical System Manager
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Hørsholm
Do you like IT system management, validation, documentation, and lots of contact with Line-of-Business? Then you might be our new colleague.
Global Pharmacovigilance & Clinical Development (GPCD) is looking for a Clinical System Manager to join GPCD. An exciting job with a high degree of individual responsibility in a dynamic atmosphere is waiting for the right candidate. The role is new to the area and you will be an integral part of defining it. Experience with system management will be a factor when selecting the candidate. The role is anchored in the GPCD IT Systems & Applications department.
About the department
Global Pharmacovigilance & Clinical Development (GPCD) consists of the clinical trials and drug safety areas. These include the Global Safety Database, CTMS system and BI-Tools as well as cloud-based systems such as eCRF, eDiary and IRT. In addition, the department is also part of cross organisational projects as well as projects with external partners.
Apart from the areas within GPCD, the IT System & Application team work closely together with our Quality Assurance Department and the Global IT Department (GBIT) as well as external stakeholders e.g. CRO's, Partners and Suppliers.
The department works in an informal, fast-paced atmosphere with multiple global stakeholders across ALK, reflecting the increasing demands from clinical trials and regulatory authority requirements.
The position
Using your knowledge and experience, your main responsibility is to contribute to the maintenance, development, and continuous improvements of the GPCD IT offerings, both Cloud based (SaaS, PaaS) and on-premises systems, to ensure functionality and compliance.
You will be expected to independently manage and drive the maintenance of one or more systems.
You will participate in implementation of changes to existing systems and/or initiation (implementation) of new systems. You will give subject matter expert input regarding regulatory requirements, business processes and validation requirements. You will be included in all levels of the projects, from soft project management to documentation of informal and formal testing.
You will also be expected to support the update of standard operating procedures, training of end-users and act as a point of entry for partners or stakeholders.
Your qualifications
You are experienced with IT system testing, validation requirements and documentation, impact assessment and stakeholder management.
The role requires a structured approach and strong analytical skills including focus on details and adherence to standards, while keeping a balanced business perspective.
It is essential that you can understand and connect regulatory requirements, business processes and functionality of IT systems.
You show initiative, are flexible and have a good sense of humour. You are open-minded, enthusiastic and a strong team-player. You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.
Allergy Solutions for Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
Application deadline
If this sounds like a mission you also would like to be part of, we hope to receive your CV and application no later than 22 January 2022.
The application must be in English.
Contact
For further information please contact Michael Kristensen, Head of GPCD Systems at +45 50 89 95 71 or Kim Erik Sonne, Head of Clinical Data Management • Biometrics at +45 61 91 31 96.
Global Pharmacovigilance & Clinical Development (GPCD) is looking for a Clinical System Manager to join GPCD. An exciting job with a high degree of individual responsibility in a dynamic atmosphere is waiting for the right candidate. The role is new to the area and you will be an integral part of defining it. Experience with system management will be a factor when selecting the candidate. The role is anchored in the GPCD IT Systems & Applications department.
About the department
Global Pharmacovigilance & Clinical Development (GPCD) consists of the clinical trials and drug safety areas. These include the Global Safety Database, CTMS system and BI-Tools as well as cloud-based systems such as eCRF, eDiary and IRT. In addition, the department is also part of cross organisational projects as well as projects with external partners.
Apart from the areas within GPCD, the IT System & Application team work closely together with our Quality Assurance Department and the Global IT Department (GBIT) as well as external stakeholders e.g. CRO's, Partners and Suppliers.
The department works in an informal, fast-paced atmosphere with multiple global stakeholders across ALK, reflecting the increasing demands from clinical trials and regulatory authority requirements.
The position
Using your knowledge and experience, your main responsibility is to contribute to the maintenance, development, and continuous improvements of the GPCD IT offerings, both Cloud based (SaaS, PaaS) and on-premises systems, to ensure functionality and compliance.
You will be expected to independently manage and drive the maintenance of one or more systems.
You will participate in implementation of changes to existing systems and/or initiation (implementation) of new systems. You will give subject matter expert input regarding regulatory requirements, business processes and validation requirements. You will be included in all levels of the projects, from soft project management to documentation of informal and formal testing.
You will also be expected to support the update of standard operating procedures, training of end-users and act as a point of entry for partners or stakeholders.
Your qualifications
- B.Sc. or M.Sc. within natural science or similar
- Minimum 2-3 years of experience within Clinical or Pharmacovigilance regulated areas
- Ability to independently manage and drive projects
- System management experience from e.g. EDC, eDiary, IRT or Safety systems
- Ability to understand various stakeholder needs, whilst maintaining objectivity
You are experienced with IT system testing, validation requirements and documentation, impact assessment and stakeholder management.
The role requires a structured approach and strong analytical skills including focus on details and adherence to standards, while keeping a balanced business perspective.
It is essential that you can understand and connect regulatory requirements, business processes and functionality of IT systems.
You show initiative, are flexible and have a good sense of humour. You are open-minded, enthusiastic and a strong team-player. You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.
Allergy Solutions for Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
Application deadline
If this sounds like a mission you also would like to be part of, we hope to receive your CV and application no later than 22 January 2022.
The application must be in English.
Contact
For further information please contact Michael Kristensen, Head of GPCD Systems at +45 50 89 95 71 or Kim Erik Sonne, Head of Clinical Data Management • Biometrics at +45 61 91 31 96.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 24.12.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Hørsholm
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