Medical Lead

1 settimana fa

Milano, Italia OPIS s.r.l. A tempo pieno

OPIS is looking for a skilled and experienced Medical Lead to join our team in Italy and take on the responsibilities for medical and safety aspects on assigned projects among other duties. The Medical Lead 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 guidelines
- Perform 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

**Requirements**:

- Degree in MD (Doctor of Medicine)
- Previous background as a Clinical Physician working in practice desirable
- Solid medical monitoring experience
- Highly effective interpersonal skills
- Fluent English, 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 opportunity to develop your professional career with a growing company.

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