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 Brazil

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

Qualifications :

• Medical Doctor degree required
• Experience as a practicing Gastroenterologist (minimum of 10 years)
• Clinical Research experience preferred
• Full working proficiency in English and Portuguese
• Proficiency with MS Office applications
• Communication presentation and analytical skills
• Problem-solving team and detail-oriented

Additional Information :

As part of PSIs Medical Monitoring team you will join our international group of medical professionals build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

Remote Work :

Yes

Employment Type :

Full-time

Experience: years
Vacancy: 1