Job Title: Clinical and Health - Sr Med Dir

Location: Remote with travel (certain clinical research sites)

Contract: 6 months

Job Description:

Nephrology

Summarized Purpose:

• Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
• Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities.
• Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR).

Essential Functions:

• Manages all medical aspects of contracted tasks across the pharmaceutical product life cycle.

General Support:

• Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to company’s corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
• Provides therapeutic training and protocol training on assigned studies, as requested.
• Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.

Clinical Trial Support:

• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
• Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
• Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
• Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.

Marketed Products Support:

• Manages signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
• Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $125.00 - $129.65 per hour, can vary depending on employment status.
• Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.

EEO and Reasonable Accommodation Statement:

Orbis Clinical provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, housing, age, disability or genetics.

We will consider all qualified applicants for employment, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.