Senior/ Medical Director, Oncology/hematology

hace 2 semanas

Desde casa, México IQVIA A tiempo completo

**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 Biotech**, we 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 #remote** **opportunity for individuals located in the **United States or Canada.**

**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
- 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

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