Medical Monitor – US Board-Certified Psychiatrist

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the main contact for trial-specific inquiries related to medical and safety issues.

• Contribute to the preparation of responses for regulatory bodies and IRBs/IECs.

• Oversee the safety of trial participants.

• Engage in activities for recruiting and retaining participants.

• Present medical topics during kick-off and investigator meetings.

• Educate trial teams on the therapeutic area and medical aspects of the protocol.

• Create and evaluate trial-specific medical-monitoring documents.

• Manage ongoing medical monitoring risks associated with the trial.

• Conduct continuous medical reviews of operational clinical trial databases.

• Provide support to Medical Reviewers, Pharmacovigilance, Medical Data Review, and Data Management teams.

• Assess protocol deviations, RAE reports, SAE narratives, IND/SUSAR Safety Reports, and annual IND reports.

• Take part in trial-related committees, including IDMC and adjudication groups.

• Review clinical study reports, encompassing safety narratives and TFLs.

• Offer medical expertise as required.

• Prepare for and participate in trial audits, addressing any findings that arise.

• Engage in feasibility evaluations for potential and ongoing trials.

• Participate in bid defense meetings and maintain client relations.

• Act as a medical expert, providing therapeutic knowledge to other departments at PSI.

⛳️ Requirements

• A Medical Doctor degree is mandatory.

• US Board Certification in psychiatry is required.

• At least 10 years of experience as a practicing psychiatrist.

• Clinical Research experience is preferred.

• Proficient in MS Office applications.

• Strong communication, presentation, and analytical skills.

• A problem-solving mindset, with a team-oriented and detail-focused approach.

• Must not require visa sponsorship for employment currently or in the future.

🏝️ Benefits

• Ability to work remotely or from home within the United States.

• Opportunity to develop a career at the forefront of medical science.

• Utilize medical knowledge and expertise to assist in delivering new medications to patients.