1MED SA, Contract Research Organization that provides clinical and regulatory services to medical device, in vitro diagnostic, pharmaceutical companies is hiring.
Are you a dynamic person, interested in an innovative and smart approach to clinical research with focus on the medical device field? What an exciting time to come on board: together with our clinical team you will be supporting MedTech companies in seeking and maintaining compliance to the new Medical Device Regulation 2017/745 requirements, generating strong and supportive clinical data with reference to medical device’s specific claims.
We are looking for a Clinical Project Manager (CPM) with at least 3 years of experience in the field to your our team!
Role with high career development opportunities.
To join us in this exciting new venture, please contact us!
– Ensure an execution on-time of the assigned clinical studies, achieving the qualitative/quantitative objectives agreed with the Sponsor;
– Refer as contact person for Investigators, Monitors, Sponsors and third parties involved in the assigned clinical trials;
– Acquire documentation produced by Sponsors and other parties in order to support the submission of a clinical trial;
– Collaborate in the creation of study documents drafts such as Protocol, Informed Consent and Case Report Form (CRF);
– Prepare and update the Trial Master File;
– Prepare the Investigator Site File to be sent to the study sites;
– Organize monitoring visits and approve related reports;
– Participate in Investigator Meetings and/or teleconferences of the assigned study and draft the related reports;
– Coordinate the data management activities, including queries management;
– Ensure the activation and the conduct of studies at the involved clinical sites, supervising the monitors;
– Provide study specific training (Protocol, CRF etc.) to the monitors and, where required, to the site staff involved;
– Manage observations made during an audit/inspection of a clinical trial and ensure that the necessary corrective actions are implemented;
– Ensure that serious adverse events are managed in accordance with the protocol and applicable laws and regulations;
– Implement and maintain the necessary procedures for the clinical trials management in accordance with GCP;
– Report major Protocol, GCP and/or SOP violations to Clinical Quality Assurance.
– Minimum 3 years of experience in clinical research of medical devices and/or drugs.
– Science Degree, biotechnology/pharmaceuticals or equivalent discipline (biology, chemistry, etc…) are preferred.
– Very good knowledge of the English language, both written and oral;
– Ability to work in a team, diplomatic skills, moral integrity, capability to maintain confidentiality in carrying out business activities;
– Good organisational skills, accuracy, attitude for in-depth analysis and perseverance in carrying out the work.
Apply to our open position and join us in this exciting new venture, becoming part of the 1MED team!