Medical Monitor (US Board-Certified Oncologist)

PSI CRO AG; United States; Remote; USD 200,000 - 250,000; Full time

Job summary

An established industry player is seeking a dedicated Medical Monitor to join their innovative team. In this pivotal role, you will provide critical medical input to global clinical studies, ensuring the utmost safety and well-being of patients. With a focus on collaboration, you will work alongside project teams, regulatory agencies, and third-party vendors to navigate complex medical matters. This is an incredible opportunity to leverage your expertise in oncology and clinical research, contributing to the development of new medications that can change lives. Join a forward-thinking organization that values both stability and innovation in the pharmaceutical field.

Qualifications

• 10+ years experience as a practicing Oncologist required.
• Clinical Research experience as Principal Investigator or Sub-Investigator is essential.

Responsibilities

• Advise clients and project teams on medical matters and ensure patient safety.
• Review clinical data and ensure compliance with protocols and regulations.

Skills

Communication Skills

Problem-Solving

Detail-Oriented

Public Speaking

Education

Medical Doctor degree

Board Certification in Oncology

Tools

MS Office

Job description

Medical Monitor (US Board-Certified Oncologist)

3 days ago Be among the first 25 applicants

Company Description
PSI is a leading Contract Research Organization with 30 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 US

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 required
• Board Certification in Oncology required
• Experience as a practicing Oncologist (minimum of 10 years)
• Clinical Research experience required, such as experience as a Principal Investigator or Sub-Investigator
• Full working proficiency in English
• Proficiency with MS Office applications
• Excellent communication and presentation skills, comfortable public speaking
• 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.

Seniority level:

Mid-Senior level

Employment type:

Full-time

Job function:

Research

Industries:

Pharmaceutical Manufacturing