- 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
- Bachelors or nursing degree required
- Advanced degree (Pharm D, PhD, or N.P.) preferred
- 5-8 years of clinical research/development experience preferred
- Minimum of 5 years of industry experience in biotech or pharma
- Effective communication (verbal & written) and presentation skills are essential
- Must be able to work productively in a fast-paced collaborative environment
- Demonstrated ability for critical thinking and sound decision-making
- Clinical experience with diabetes trials strongly preferred
- Previous big pharma/biotech experience – phase II and III trials
- Ability to travel to Charlottesville, VA on a quarterly basis or as required for important team meetings
- Demonstrated ability to collaborate well with others
- Self-motivated and eager to learn new skills and contribute to the success of the organization
- Willingness to "roll up sleeves" in a start-up environment
- Compensation commensurate with experience
- Company offers a full suite of benefits including an incentive stock option program
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Clinical Scientist - Charlottesville, United States - RIVUS PHARMACEUTICALS INC
4 days ago
Description
Job Description
Job DescriptionClinical 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:
Skills and Qualifications:
Other:
