About the job
IQVIA Biotech is seeking an Oncology and/or Hematology, Board Certified or Eligible physician for the position of Senior/ Medical Director, Medical Monitoring. 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 Home-Based opportunity for individuals located in the United States, Canada, Argentina, Brazil and Mexico.
A full description of the Major duties of the Medical Director are outlined below:
Per sponsor request, 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
Functions as project team member
Provides project team with training on therapeutic indication and/or treatment modality
May provide study team with 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 which may include per sponsor request individual calls to key opinion leaders, investigators and site staff, and participation in teleconference and virtual presentations
Per sponsor request, presents protocol and/or safety reporting information at investigator meetings
Develops project medical monitoring plan
Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues
Provides medical input into the development of study protocols, training materials, informed consent, Investigator Drug Brochures, analysis plan designs, clinical study reports, regulatory approval submissions
Provides on call coverage for protocol queries and site support
Safety Monitoring and SAE Reporting Activities:
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
Per sponsor request, reviews IND/SUSAR Safety Reports, updates to Investigator Brochures, and annual IND reports with sponsor data
In consultation with the sponsor, follows procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)
Interacts with regulatory officials concerning safety and other study related issues, as requested
Provides medical review of eCRFs and edit check specifications for clinical accuracy
When indicated, provides Medical Data Review Plan as appendix to the Medical Monitoring Plan
Performs medical review of coded terms (e.g. adverse events, concomitant medications and medical history) for medical accuracy and consistency
Provides individual and aggregate review of clinical data as requested and specified in the Medical Data Review appendix
Reviews laboratory data as requested by sponsor and as specified in the MMP or Medical Data Review Appendix
Reviews data tables, listings, and figures as requested by sponsor
Reviews and/or writes portions of final clinical study report as requested by sponsor
Business Development Activities:
Works with Business Development to actively solicit new business for IQVIA Biotech, including assistance with marketing presentations and proposal development
Interacts with clients regarding drug development programs, study design and protocol development
Reviews and provides medical and scientific input to new business proposals
Participates in feasibility discussions relating to specific project proposals
Supports business development activities with proposal development and sales presentations
Obtains literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.
Assists with drafting of standard operating procedures and working practices regarding Medical Director activities
Participates in a variety of team quality improvement efforts as necessary
Performs other related duties as assigned or requested by the Vice President, Medical or designee
KNOWLEDGE, SKILLS, AND ABILITIES:
Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus
Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment
Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities
Excellent oral and written communications skills as well as interpersonal skills are essential
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
Ability to travel domestically and internationally as required
Very limited physical effort required to perform normal job duties
MINIMUM RECRUITMENT STANDARDS:
Current or prior license to practice medicine; board certification/eligibility ideal
10 years’ experience relevant to drug development and clinical research, including 3-5 years of biopharmaceutical industry, academic, and/or clinical practice experience
Oncology And/or Hematology Board Certification Or Eligibility Required
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
IQVIA is an EEO Employer – Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at email@example.com to arrange for such an accommodation.
- Health Care Provider
- Total Years Experience 0-5
- Remote Work Full-time remote work