Offre d'emploi : Clinical Data Manager & SAS Programmer (M/F)
Miracor Medical is a European medical device company specialized in improving the clinical outcome of patients with impaired cardiac function (specifically acute myocardial infarction), active in interventional cardiology. The company has developed a high potential class III and IIb proprietary technologies that consists of hardware, software and catheter(s).
The technology is well-advanced in a randomized clinical trial in ST-Elevation-Myocardial Infarction (STEMI) patients, with various potential additional therapeutic applications. The company has received in 2020 CE Mark for its proprietary catheter and console and expects approval from FDA to run a pivotal Investigational Device Exemption (IDE) study in 2022. During 2021, Miracor has initiated a first focused commercialization of its products.
Miracor Medical (www.miracormedical.com) offers a culturally diverse English-speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities. The offices are based in Awans near Liege.
In order to strengthen the clinical department, we are looking for a (m/f) : Clinical Data Manager & SAS Programmer.
Reporting to Miracor Medical’s VP Clinical Affairs Europe, the Clinical Data Manager (CDM) oversees all the clinical information of the different projects. The CDM is responsible for the design, storage and analysis of data collected in clinical trials. This includes creation of data standards, working with cross-functional teams (Study managers, core labs and other service providers) and third-party vendors (CROs) to assure quality within the data management life cycle.
- Contribute to the Company Quality Objectives by ensuring quality and accuracy of research data.
- Liaison with project staff and external parties to determine data collection and reporting requirements.
- Designing and testing or assisting in the design of electronic data collection systems.
- Assisting in the design of Case Report Forms or other data collection tools according to study protocol with CROs and vendors.
- Contribute to the set-up and the supporting study set-up, conduct and closeout documentations.
- Maintaining systems for data collection.
- Generate and manage the data queries (including inconsistent, missing and incorrect data) generated by the electronic data collection systems.
- Contribute to the delivery of a clean database and the database lock activity, after communicated with the project teams.
- Designing and generating data management plans and reports for projects.
- Participate in the development and validation of new data management systems and processes if necessary.
- Creating data listings and tables in SAS where applicable.
- You hold a MSc or PhD in a scientific field with a strong statistical content.
- 10+ years of relevant work experience in clinical data management in the pharmaceutical/ biotechnology industry.
- Knowledge around SAS programming to coordinate and query datasets using BASE/SAS.
- Demonstrable experience in clinical/data management facilitating data management and data science activities with (non)clinical experience.
- Solid understanding of ICH and FDA relevant guidelines for data management activities and on CDISC standards (CDASH, STDM and ADaM).
- Knowledge of ISO14155:2020 and MDR is an asset.
- Deep understanding of data life cycle for data from product development to registration of regulated products.
- Experience in oversight of CRO activities.
- Excellent written, verbal and organizational skills.
- Must be detail oriented and have strong prioritization skills.
- Ability to handle multiple projects and be a team player.
- A diversified position within a high-potential innovative medical device company.
- To work in a human size, dynamic, respectful, and professional environment.
- International exposure, with learning and development opportunities.
- An attractive salary package in line with the position responsibilities and your experience.
Send your CV together with an adapted cover letter via https://www.pahrtners.be/en/jobs/clinical-data-manager-sas-programmer-mf-en/ or to the following address: firstname.lastname@example.org.
Your application and related information will remain strictly confidential.