Remote
PSI CRO

Director of Medical Monitoring and Consulting

  • Remote, Remote
  • Full-time

Company Description

We’re over 1600 strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for Teamwork across all our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way.

You are dynamic. You are curious. You are more than your job.For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we’re looking for.

Job Description

Join a company that has consistently high performance. We understand the delicate balance between the science and art of delivering quality service to every study we manage. Whatever we do, our work is on the critical path to having an impact on someone’s life.

The Director of Medical Monitoring and Consulting will actively participate in all aspects of Clinical Research, working collaboratively with the Clinical Study Team and contributing to the strategic planning and execution of Clinical Plans in Hematology and Oncology.

Responsibilities:

  • 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

Qualifications

Education/Knowledge Requirements:

  • M.D. degree; oncology or hematologist-oncologist
  • Board certified with an active US medical license
  • Minimum 10 years total clinical research 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