Medical Monitor (Gastroenterology)

As a Medical Monitor at PSI, you will be responsible for providing critical medical input for clinical studies related to gastroenterology. Key duties include being the primary medical contact for project teams and study sites, reviewing clinical data to ensure patient safety, advising on medical matters, and collaborating with various departments to ensure compliance with FDA, EMEA, and GCP guidelines.

To become a Medical Monitor at PSI in Riga, you must hold a Medical Doctor degree with a Gastroenterology Fellowship certification. Additionally, having a minimum of 10 years of experience as a practicing MD and familiarity with clinical trials is often considered beneficial, alongside strong communication and analytical skills.

At PSI, we foster an inclusive culture that values diverse perspectives and experiences. This approach creates a supportive environment where Medical Monitors can thrive. We believe that every team member has an opportunity to contribute significantly to our mission of advancing medical science, and we prioritize collaboration and professional growth.

Medical Monitors at PSI play a vital role in patient safety by closely reviewing clinical data and ensuring adherence to protocols. They also address any safety issues raised during the study and collaborate with safety monitoring boards to implement effective risk mitigation strategies, ultimately prioritizing patient wellbeing throughout the trial process.

The work of a Medical Monitor at PSI is crucial to the success of clinical trials. By ensuring patient safety, compliance with regulatory standards, and providing essential medical insights, they contribute directly to bringing innovative treatments and medications to patients. Their expertise helps shape the future of healthcare.

To ensure compliance with GCP guidelines, I regularly review all study-related documents, conduct thorough training sessions for the study team, and maintain open lines of communication with stakeholders. Additionally, I keep abreast of current GCP requirements and emphasize the importance of adhering to these standards to all team members.

In a previous role, I encountered a situation where unexpected adverse events were reported in a trial. I quickly organized a meeting with the project team to assess the situation, initiated further investigation with study sites, and worked closely with the Data Safety Monitoring Board to implement immediate risk mitigation strategies that ensured patient safety.

When reviewing clinical data, I first establish a systematic approach to ensure all data points are measured accurately. This includes scrutinizing data for inconsistencies, identifying trends, and cross-referencing with clinical reports. I also engage with the data management team to clarify any uncertainties, ensuring comprehensive feedback.

Collaboration with cross-functional teams is paramount. I make it a point to communicate goals clearly, hold regular check-ins with relevant team members, and document decisions made during meetings. This fosters an environment of openness and ensures that everyone is aligned towards the same objectives.

My experience with clinical trial documentation involves preparing and reviewing essential documents such as protocols, informed consent forms, and clinical study reports. I ensure these documents accurately represent the clinical processes and comply with regulatory requirements, thereby facilitating a smooth review process.

In pharmacovigilance activities, I monitor and evaluate adverse drug reactions reported during clinical trials. I compile and analyze data, report findings to the relevant regulatory bodies, and recommend safety measures. My goal is to ensure thorough evaluation and communication of any safety concerns throughout the trial.

I stay updated with the latest developments in gastroenterology by regularly reading reputable medical journals, participating in conferences, and engaging with professional organizations. Continuing education is essential to my role, and I value the opportunity to learn from peers and experts in the field.

To identify and mitigate risks during a clinical trial, I conduct risk assessments at planning stages, assign responsibility for monitoring specific risks, and create contingency plans. Furthermore, I encourage open communication within teams so that any potential risks are flagged early, allowing for timely interventions.

Effective communication with investigators and sponsors is critical. I maintain regular contact through scheduled meetings, provide clear and concise updates, and establish trusted relationships. This ensures that all parties remain informed about the trial's progress and any issues that arise.

What inspires me most about working in clinical research is the opportunity to contribute to meaningful advancements in patient care. Knowing that my work plays a role in developing new treatments that can improve lives is incredibly fulfilling. It drives my passion for ensuring the highest standards of safety and effectiveness in our trials.