Offer summary

Qualifications:

Medical Doctor degree, Internal Medicine certification required, Minimum 10 years medical practice experience, Clinical trial experience preferred, Proficient in English and Spanish.

Key responsabilities:

Advise on medical matters for clinical studies

Collaborate on clinical development documents and presentations

Ensure data safety and compliance with protocols

Participate in safety monitoring and risk management

Review and sign off clinical documents for relevance

Job description

Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

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:

Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
Review and analysis of clinical data to ensure the safety of study participants in clinical studies
Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
Address safety issues across the study from sites and the study team
Review listings for coded events to verify Medical Dictionary for Regulatory activities
Participate in bid defense meetings
Assist in Pharmacovigilance activities
Identify Program risks, and create and implement mitigation strategies with Clinical Operations
Ability to organize and lead clinical development advisory boards and safety monitoring boards
Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
Review and sign off clinical documents with respect to medical relevance.

Qualifications

Medical Doctor degree
Internal Medicine certification is a must
Prior and wide experience in medical practice/patient care (minimum of 10 years)
Prior experience working with clinical trials is a plus
Prior experience with ICU is a plus
Full working proficiency in English and Spanish
Proficiency with MS Office applications
Communication, presentation and analytical skills
Problem-solving, team and detail-oriented

Additional Information

As part of PSI's 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.

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