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Ferring Pharmaceuticals A/S, Copenhagen
Would you like to join us in a challenging position as project statistician within the Biostatistics department of Global Biometrics?
The Biostatistics department is, next to Statistical Operations and Data Management, part of Global Biometrics. You will be working closely with peers located in the US, China and Japan. You will be reporting to the Senior Director, Biostatistics in Ferring Pharmaceuticals IPC, Copenhagen, and be part of a relatively small highly professional team.
As a project statistician, you will be overall responsible for:
- clinical trial designs (phases I-IV) and its operating characteristics
- programming preparations with primary focus on statistical inference
- central statistical monitoring using SAS JMP-Clinical functionality.
Coloplast A/S, Humlebæk
Are you data driven and looking for a role where you can impact the execution of our clinical studies?
Your job as a Data Manager (DM), is to prepare databases and administer study data for final analysis. You will get the opportunity to follow the investigations from the very start of the planning phase to the end of the study and thereby be involved in different phases of the investigations. With more detail, the tasks are to:
- Prepare case report forms (questionnaires), data management plans, as well as study validation plans and reports
- Set up the database and data entry screens, planning, coordinating and managing data entry activities
- Validate clinical data (set-up and testing of edit checks, query handling and quality control of the data)
Unomedical A/S, Osted
We are looking for an experienced Clinical Specialist who can drive the clinical area from a regulatory perspective with excellence within ConvaTec Infusion Care. We are located at Osted, approx. 40 minutes' drive from Copenhagen.
You have an in-depth knowledge of medical writing and will be responsible for writing and developing Clinical Evaluation Reports (CERs) under the MEDDEV 2.7/1 revision 4 and EU MDR guidelines.
- Prepare and update Clinical Evaluation Reports in accordance with MEDDEV 2.7.1, EU MDR guidelines, and internal SOPs
- Analyze pre-clinical and clinical data, risk management assessments, published literature results, post-market surveillance data, and field performance data to evaluate product safety and performance