
1001 - 5000 employees
Founded 1996
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.
🕒 August 10
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1001 - 5000 employees
Founded 1996
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.
• Act as the primary point of contact for trial-specific medical and safety-related questions • Provide input for responses to regulatory authorities and IRBs/IECs • Monitor trial participant safety • Participate in participant recruitment and retention activities • Present medical matters at kick-off and investigator meetings • Train trial teams on the therapeutic area and protocol medical aspects • Develop and review trial-specific medical-monitoring documents • Manage ongoing trial risks related to medical monitoring • Perform ongoing medical review of operational clinical trial databases • Support Medical Reviewers, Pharmacovigilance, Medical Data Review, and Data Management • Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR Safety Reports, and annual IND reports • Participate in trial-related committees, including IDMC and adjudication committees • Review clinical study reports, including safety narratives and TFLs • Provide medical expertise on an as-needed basis • Prepare for and participate in trial audits and follow up on findings • Participate in feasibility assessments of potential and ongoing trials • Participate in bid defense meetings and client interactions • Act as a medical expert and provide therapeutic expertise to other PSI departments
• Medical Doctor degree required • US Board Certification in psychiatry required • Minimum of 10 years’ experience as a practicing psychiatrist • Clinical Research experience preferred • Proficiency with MS Office applications • Communication, presentation, and analytical skills • Problem-solving, team-oriented, and detail-oriented approach • Must not require work visa sponsorship for employment now or in the future
• Remote work / home-based in the United States • Opportunity to build a career on the frontline of medical science • Use medical knowledge and expertise to help bring new medications to patients
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