Clinical Scientist

Job Description

Job Description

Clinical Scientist :

Clinical Scientist, Manager Level

About Us :

Rivus Pharmaceuticals is a privately held pharmaceutical company located in Charlottesville, VA, that is dedicated to improving cardio-metabolic health by developing controlled metabolic accelerators (CMAs) that address the underlying metabolic risk factors for cardiovascular mortality and morbidity. We are looking for a new member to join our clinical team.

Job Description :

The Clinical Scientist will work closely with their supervisor and other members of the cross-functional study team to author and contribute to clinical development documents and facilitate execution of study activities and data summarization.

Duties :

• Clinical development strategic and tactical input
• Protocol development
• Reviews study related documents such as : medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc.
• Trains and supports study team and CRO personnel regarding clinical aspects of trial
• Accountable to the Clinical Lead for the project for a specific trial for : first-line medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
• Maintains and develops relationship with key study investigators, organizes steering committees, advisory boards, and data safety monitoring boards as required
• Identifies program, trial, or data risks, then creates and implements mitigation strategies
• Responsible, with input from Medical Monitors, Clinical Trial Management Biostatistics and Data Management for timely clinical data review and quality of deliverables
• Reports to supervisor and management on clinical trial findings and milestones

Skills and Qualifications :

Other :