Clinical Research Coordinator – Digital Medicine
2-year fixed-term contract (extendable); full-time, start date : Asap
A Clinical Research Project Coordinator position is available at the Digital Medicine (dMed) group / Centre d’Investigation et d’Epidémiologie Clinique (CIEC). The dMed group is headed by the FNR-PEARL Chair Prof. Dr. med. Jochen Klucken and focuses on shaping and innovating personalized digital healthcare solutions and integrating them into the rapidly growing new ecosystem for digital medicine. We conduct clinical research on digital technologies and evaluate digital tools such as digital therapeutics and diagnostics jointly with the University Luxembourg (LCSB), the Centre Hospitalier de Luxembourg (CHL), the Luxembourg Clinical and Translational Research Centre (LCTR), and the Parkinson Research Clinic (PRC). Patient-centred digital healthcare services, smartphone-based or web-based, have the potential to address patients’ needs, continuously monitor and manage individual patient journeys, and provide clinical decision support for the healthcare provider.
- Assist Strategic development of the dMed group
- Support grant applications, project management and clinical study design that aim to evaluate the patient-centric value of digital therapeutics and diagnostics.
- Coordinate a portfolio of clinical research studies according to the contract/scope of work, protocol, budget (setup financial contracts and manage financial aspects during the projects) and fixed timelines including track and report on deliverables/timelines, and costs vs. budget.
- Supervise and assist in the regulatory submissions (national and international to health authorities and the national research ethics committee) according to the applicable laws, administrative and regulatory requirements and obtain approvals.
- Support private sponsors, researchers and investigators from other research institutions or hospitals in the setup (contract, admin, approvals, timelines, budget, etc.) and conduct of clinical research projects.
Key Skills, Experience and Qualifications
- PhD in the field of Medical/Health, Biomedical, or Life Sciences or pharmacy or Biology/Biotechnology related sciences is recommended.
- Relevant job-related experience in clinical research study management
- Ability to drive projects forward focusing on the deliverables, to interact positively with advisors and regulatory authorities.
- Excellent communication and collaborative skills to work as an interface in a multi-disciplinary environment
- Highly committed, ability to work independently, meticulous with attention to detail
- Language skills: Fluent in French and English. Any other commonly spoken language in Luxembourg such as Portuguese, German or Luxembourgish would be an added advantage.
- Good knowledge of MS Office (Word, Excel, PowerPoint).
- Experience in multi-center international clinical research projects.
- Knowledge of the clinical research working rules in Luxembourg/Belgium and Europe (legal context, patient rights, data protection, etc.) and the international directives (International Conference on Harmonization - Good Clinical Practice: ICH-GCP) as well as the Clinical trials - Directive 2001/20/EC replaced by the Clinical Trials Regulation and biobanking recommendations and guidelines (ISBER; etc.).
- Knowledge of regulatory requirements for clinical trials.
- Certified clinical research (DIU-FARC, DIU-TEC, etc.) or biobanking certificate.
- PRINCE2 or equivalent; experience in a PM tool (MS project or equivalent).
Located in Luxembourg, LIH offers the opportunity to work in a dynamic, international and multilingual environment that values personal respect and professional achievement based on the highest intellectual and ethical standards. The remuneration for this position shall be based on qualification and experience.
Applications including a cover letter and a curriculum vitae should be sent before 24 April 2022 with the ref: VD/CRC0322/JK/DMed.