Medical Monitor (Gastroenterologist)

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Home-Based in Mexico

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

• Monitors trial participant safety

• Participates in trial participant recruitment boost and retention activities

• 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

• Performs 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/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)

• Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)

• Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases

• Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)

• Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable

• Prepares for and participates in trial audits, follows up on audit findings

• Participates in feasibility assessment of potential and ongoing trials in the country/region

• Participates in bid defense meetings and other interactions with clients

• Acts as a medical expert and provides therapeutic expertise to other PSI departments

• Medical Doctor degree required

• Experience as a practicing Gastroenterology (minimum of 10 years)

• Clinical Research experience preferred

• Proficiency with MS Office applications

• Communication, presentation and analytical skills

• Problem-solving, team and detail-oriented