In this role you are required to
* Perform clinical studies under scientific and legal guidelines, in collaboration with the project leader or Head Clinical Operations
* Prepare, conduct and follow-up on site initiation visits, site monitoring visits and site close-out visits of the involved clinics (on-site and remote)
* Make short and long-term plans to monitor involved clinics to ensure data quality and compliance
* Prepare and develop documents for public authorities and/or ethics commission submissions
* Develop and adapt Case Report Forms (CRFs)
* Control quality and collection of clinical data
* Update Project Managers regarding the documentation quality of the clinics and report regularly on the general status of the participating site
* Prepare and implement solutions, in collaboration with the project leader or Head Clinical Operations, to maintain or adapt the project timelines, budget and scope
* Maintain contact with Principal Investigators and Study Coordinators and provide them support to conduct the clinical investigation
* Prepare and develop Study Newsletters
* Prepare clinical data for analysis in collaboration with the project team, including Study Assistant, Data Manager and Statistician
* Assist in optimizing quality standards and SOPs
* Assist the study assistant and the project team to ensure reimbursements to the clinics as required
To master this challenge, you have
* A Bachelor in Natural Science, nursing degree
* Further education in Clinical Research and basic medical knowledge
* Good understanding of study-related outcome measures
* Experience with data capture in the field of clinical research
* Strong organizational and follow-up skills
* Attention to detail and reliability
* Ability to work both independently and in a team
* Flexibility and customer-focused mindset
* Strong written and oral communication skills in English