IQVIA R1162317 Medical Monitor, Ophthalmology (Contract) - IQVIA Biotech in Boston, Massachusetts
Immediate contract opportunity for an # Ophthalmology Medical Monitor, Independent Consultant.
The principal function of a consulting Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as a medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators and study team members on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues.
Ophthalmology Board Certification/ Eligibility
Doctor of Optometry candidates will be considered licensure
Previous Clinical Research Organization Medical Monitoring experience
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.
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
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 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com .
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.
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 firstname.lastname@example.org to arrange for such an accommodation.
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
- IQVIA Jobs