Reporting to Clinical Research Manager you will be responsible for overseeing the progress of a clinical trial, typically on-site, and ensuring that the trial is conducted, recorded and reported in accordance with the protocol, study guidelines, SOPs, and applicable regulations.
- Conducting trial/site management in accordance with protocol, SOPs, LOPs, ICH-GCP guidelines and local legislation, including sites selections, obtaining necessary approvals and documentation, site initiations, monitoring and SDV, management of site recruitment performance, trial supplies management, handling of safety information, data cleaning activities, close-out and archiving.
- Achieving close liaison with Project Management, Data Management and HQ throughout the trial to ensure milestones achieved.
- Updating required IT Systems following every site visit.
- Work according to local law, Business Ethics, NNWay and NN policies & guidelines.
Requisitos del candidato
De 1 a 3 años
- Life Sciences Degree, ideally with a post graduate qualification in Research.
- At least 2 years’ experience in monitoring trials in accordance with ICH GCP methodology.