Medical Monitor

Medical Monitor - Italy - great opportunity

Who we are:

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science-driven biotech-focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.

The role:

OPIS is looking for a skilled and experienced Medical Monitor to join our team in Italy and take on the responsibilities for medical and safety aspects on assigned projects among other duties. The Medical Monitor will actively participate in all aspects of clinical research, working collaboratively with the clinical study team and reporting to the Medical Director.

Some of what you'll do:

• Prepare materials and actively participate at investigator meetings and site initiation visits per study needs
• Perform medical support in feasibility activities
• Assist with data safety monitoring board activities if and when needed
• Develop training modules and materials, and provide training in disease indications and protocol specific requirements across the company
• Participate in training opportunities to advance knowledge of drug development and good clinical practice guidelinesPerform medical data review – reviews laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed
• Perform medical monitoring activities – review eCRF, act as a reference medical person for investigators and sponsors
• Medical review and support to safety department in execution of SAEs on assigned projects
• Review and assist in finalization of CSR (Clinical Study report) or other study related documents (Protocol, ICF, etc.)
• Provide 24/7 medical support in clinical trials

Work & Education Minimum Requirements

• Degree in MD (Doctor of Medicine) is mandatory
• Previous background as a Clinical Physician working in practice desirable
• Solid medical monitoring experience
• Highly effective interpersonal skills
• Fluent English and Italian, written and verbal
• Good planning, problem solving and organizational skills
• Able to manage multiple activities and different priorities simultaneously
• Able to interact with Sponsors

We offer a competitive salary with other benefits and opportunities to develop your professional career in a CRO, world-wide, with an expanding and growing research company.