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Senior/ Medical Director, Oncology/Hematology, IQVIA Biotech

aplique agora
Localizações: Cidade do México, Ciudad de México Full time R1323535

Job description

Senior/ Medical Director of Oncology and/or Hematology

Improving the expectations for human health isn’t easy, but we are determined. Together, we​ are on a path to achieving this vision. At IQVIA Biotechwe share a passion for the greater good, a collaborative spirit, and endless curiosity. Each day is another opportunity to find new solutions and enable the next breakthrough.

Join us here at IQVIA Biotech where we foster a culture of inclusion and a commitment in which people from all backgrounds can fully contribute to the growth and success of our business and by making use of a diverse range of thoughts, experience, and skills.

Join us as a Senior/ Medical Director of Oncology/ Hematology and be part of our expanding Medical Services division. Applicants with current clinical research industry and/or academic clinical research experience will be considered.

As a member of our medical team the primary role of Senior/ Medical Director is to serve as Medical Monitor for studies conducted by IQVIA Biotech on the behalf of biopharmaceutical sponsor companies. In the role of Medical Monitor, the Senior/ Medical Director provides medical oversight as the first line of support for clinical trials and ongoing clinical trial management. As the assigned lead Medical Monitor, the Senior/ Medical Director involvement begins with early client engagement, strategy, proposal development and sponsor relationship management. The essential duties required include creation of medical monitoring plans, development/review of clinical protocols, medical safety, and aggregate data review.

Excellent #remoteopportunity for individuals located in the United States or Canada.

For immediate consideration please contact me via email @ Angela.Lucas@iqvia.com

Summary

Minimum requirements:

  • Current or prior license to practice medicine; board certification/eligibility ideal
  • 7 - 10 years’ experience relevant to drug development and clinical research, including 1 -3 years of biopharmaceutical industry, academic, and/or clinical practice experience

Responsibility

Medical Monitoring

  • Reviews and provides input for protocol development; interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints; interacts in a team approach to develop statistical and data management sections of the protocol; reviews the final protocol for clinical, safety and efficacy variables
  • Assistance in developing criteria for investigator site selection and networking for potential investigators for study participation, and aid in review and final selection
  • Participates in subject recruitment and retention activities
  • Develops project medical monitoring plan
  • Works with the IQVIA Biotech or vendor Safety Management Department to provide medical review and case assessment of SAEs/UADEs including review and edits of SAE narratives and safety queries, follow-up on outstanding safety queries, and interacting with sponsors and investigative sites to discuss safety issues as needed  
  • Provides medical review of eCRFs and edit check specifications for clinical accuracy
  • Performs medical review of coded terms (e.g. adverse events, concomitant medications and medical history) for medical accuracy and consistency
  • Reviews and/or writes portions of final clinical study report as requested by sponsor
  • Works with Business Development to actively solicit new business for IQVIA Biotech, including assistance with marketing presentations and proposal development

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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