Medical Monitor
Some of what you'll do:
- Responsible for medical and safety monitoring on assigned projects;
- Performs medical feasibility activities;
- Performs medical data review – reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed;
- Performs medical monitoring activities – reviews eCRF, acts as a reference medical person for Investigators and Sponsors;
- Reviews clinical study protocols, investigator brochures, informed consents and supports their development
- Prepares materials for investigator meetings and site initiation visits;
- Actively participates in investigator meetings and site initiation visit;
- Interacts with interdepartmental and external consultants as appropriate;
- Assists when needed with data safety monitoring board activities;
- Develops training modules and materials, and provides training in disease states and protocol specific requirements across the Company;
- Participates in training opportunities to advance knowledge of drug development and good clinical practice guidelines;
What we're looking for:
- Doctor of Medicine
- Previous work as clinical investigator and/or experience in clinical trials is preferred
- Therapeutic expertise in cardiovascular disease is appreciated
- Medical monitoring solid experience
- Highly effective interpersonal skills
- English fluent
- Italian is a plus
- Good planning, problem solving and organizational skills
- Able to manage multiple activities and different priorities simultaneously
- Able to interact with Sponsors
What we offer:
We offer a competitive salary, bonuses, and other benefits together with the opportunity to develop your professional career with an expanding and growing international company.
Please read the information notice on the processing of personal data in the candidates’ information section of our company website.
Who we are:
OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.