PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on 'on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that ...
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Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage
Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials
Collaborate with Project Management, Clinical Operations and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts and different scientific presentations
Identify Program risks, and create and implement mitigation strategies with Clinical Operations
Responsible for review and analysis of clinical data including safety monitoring
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
Desired Skills and Experience
M.D. degree; Oncology or Hematologist-oncologist
Board certified in Oncology or Onco-hematology, with an active medical license
Minimum 10 years clinical experience
Knowledge of key opinion leaders in the areas of oncology/hematology highly desirable
Familiar and comfortable with clinical concepts, practices and FDA regulations regarding clinical research trials experience with FDA interactions leading to drug approval strongly preferred
Familiar with data processing methods plus general knowledge of clinical medicine, oncology and medical terminology
Ability to interact with and train clinical monitors and physician investigators, and build constructive, trusting and respectful relationships with colleagues at all levels within and outside the organization
Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance
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