Medical Monitor (US Board-Certified Psychiatrist)

Responsibilities

• Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions
• Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions
• Maintains trial participant safety
• Promotes trial participant recruitment and retention
• Presents on medical matters at kick-off and investigator meetings
• Trains trial team in the therapeutic area and medical aspects of the protocol
• Develops and reviews trial-specific documents within the scope of medical monitoring
• Manages ongoing trial risks related to medical monitoring
• Conducts ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial
• Reviews protocol deviations
• Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
• Reviews IND/SUSAR Safety Reports, updates/amends to essential trial records, and annual IND reports with sponsor data (per sponsor request)
• Supports management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)
• Serves as a medical expert and provides therapeutic expertise to other PSI departments
• Prepares for and participates in trial audits, follows up on audit findings
• Assists in the feasibility assessment of potential and ongoing trials in the country/region
• Participates in bid defense meetings and other interactions with clients

Qualifications

• Medical Doctor degree required
• US Board Certification in psychiatry required
• Experience as a practicing psychiatrist (minimum of 10 years) preferred
• Clinical Research experience preferred
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented