id: NDk1NTg1MSA3

reference: 4955851

documentId: 4955851

connectionPointId: 7

lastModificationDate: 1551949946393

stillingsbetegnelse: Clinical Data Manager

jobbeskrivelse:

Are YOU ready for a career change? Perhaps you are currently working as a nurse at a University Hospital involved in clinical trials and you would like to change seats and now work in the Pharma Industry? Or you are currently working in Pharmacovigilance (e.g. as Drug Safety Associate) and would like to change into the clinical trial area? Or you have just finished your M.Sc. or Ph.D. in a pharma or data related area? Here comes the possibility to the change into a role as Clinical Data Manager in LEO Pharma, R&D. An interesting job, making a difference for patients with skin conditions.

About the Job

In LEO Pharma Patient, People and Performance matters. We have an exciting 2025 strategy and a strong pipeline- well balanced with many projects in early-stage as well as in late-stage development.

As Clinical Data Manager you will be responsible for accurate, timely and consistent clinical data. You will provide clinical data management support to cross functional trial teams.

You will have the opportunity to work with world-wide:

Phase I trials: First-in-man trials

Phase II trials: Dose-finding trials

Phase III trials: Confirmation safety and efficacy trials

Phase IV trials / Non-interventional Studies: Safety trials in real life setting

You will assume a large variety of tasks and responsibilities within the Data Management area, both with hands-on work and CRO oversight. You will develop (and have oversight of) the data management processes from trial set up to closure of the clinical data bases. You will learn to specify CRFs on how to collect data, set-up databases and write Data Management Plans on how to ensure correct data for analysis. You will learn how to do data processing (cleaning), reconciliation of data sources and how to do database lock – always with high quality data and a good sense for proper documentation. You will work closely together with Data Management CROs and EDC vendors. You will become of a part of the team of Data Managers in the Biometrics Department and you will be working with your DM colleagues in an organisation where knowledge sharing and team work is key. In DM we are willing to go the extra mile, while at the same time keeping a good a sound work-life balance.

You will be responsible for the DM area as a member in the clinical trial team and will be working closely with the statistical programmer, statistician, safety advisor, medical experts and the trial manager within the frames of Global Clinical Operations.

Your Qualifications

You are an educated Nurse, B.Sc or M.Sc in Pharmacy, Pharmaconomist, Biomedical Engineer (B.Sc or M.Sc) or M.Sc. or Ph.D. within natural or computer science. 

You have proven training in databases and IT systems, e.g. EDC systems. You have minimum 3 years of job related experience.

You must be eager and fast to learn, self-driven, with strong collaboration and communication skills. You must be a positive team player with a good sense of humor.

You are fully proficient in both written and spoken English. You must be able handle MS Word, Excel, Power Point with ease. GCP training will be an advantage. Programming skills will also be an advantage.

We offer

• An exciting environment, with a high degree of influence on own job 
• You will be part of an engaged DM team and as member of this team you will be part of setting the direction for the future 
• Skilled colleagues in the trial teams, in a learning and international organisation 
• Support in getting up to speed as Clinical Data Manager. We will offer a training program with a mentor / buddy 

The position refers to Head of Data Management, Lisbet Groes.

Apply:

Deadline to apply for this job is March 19, however we will assess the applications on an ongoing basis, so please submit your application at the earliest possible convenience and we will contact you asap.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2149

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR