The Clinical Data Manager will join the LIH’s Competence Center for Methodology and Statistics (CCMS).
Within the Department of Medical Informatics, the CCMS provides methodological support in statistical planning as well as analysis & data handling for various laboratories and research groups. It also offers training in statistics and support in writing papers.
To support the team on clinical epidemiological and translational research projects, we are seeking a Clinical Data Manager. The role involves supporting data management (data flow, pseudonymisation, interoperability, data entry, data curation) and will be responsible for data validation (e.g. “edit checks”) to control the quality and integrity of recorded data. He/she will also support regulatory, quality, confidentiality and security compliance for the data.
Key Accountabilities

• Support/prepare drafting of data flows according to the statistical analysis plan defined by the statistician and the researcher;
• Participate in the drafting and update of documents related to data management such as the data management plan, the “Code Book”/definition of the data model or terminologies, the data validation plan, monitoring plan and stemming queries;
• Verification and report of data practices to the data controller for compliance;
• Monitor data input to ensure completeness and accuracy, implement and monitor quality control measures, identify and correct data errors or inconsistencies;
• Document project files in the record management system and ensure adherence to data management standard operating procedures, maintaining traceability in quality folders;
• Organize and manage project files in accordance with the Institute's guidelines and instructions;
• Follow internal policies, notably regarding data;
• Communicate with consortium partners to enable a smooth data processing throughout the project;
• Attend and contribute to operational committees, steering committees, multidisciplinary working groups and other project-related meetings;
• Participate in the preparation of presentations for congresses, proofreading of reports.

Key Skills, Experience and Qualifications

• Master level diploma with a specialization in Clinical Data Management and knowledge of IT data structures and databases design;
• Min. 3 years of experience in Clinical Data Management or healthcare systems development;
• Experience in managing big data (e.g. Real world data (RWD), Public health record (PHR) , Electronic health record (HER), omics data…);
• Knowledge of medical interoperability data standards such as OMOP CDM, Open EHR, HL7 FHIR, CDISC and terminologies SNOMED, LOINC, ATC, MEDDRA, etc.;
• Strong organizational and interpersonal skills, teamwork, attention to detail, analytical abilities, capacity to handle a significant workload, and meet deadlines, customer service-oriented;
• IT skills: Python, SQL, Git;
• Data Management Systems: SAS, Ennov Clinical, Red Cap, …;
• Languages skills: fluent command of French and English;
• Knowledge of Good Clinical Practices (GCP) is an asset.

Applications including a cover letter and curriculum vitae should be sent before 15 September 2024 via our website https://www.lih.lu/en/careers/ Ref.: MC/CDM0824/MV/CCMS
Gender Equality
The LIH is an equal opportunities employer. We are fully committed to removing any discriminatory barrier related to gender, and not only, in recruitment and career progression of our staff.
The LIH is attentive to gender representation among its leadership staff and aims to eliminate obstacles to the recruitment and promotion of female leaders and their career development.