Senior Medical Director - Biopharma Europe (Homebased)

IQVIA ,
Stevenage, Hertfordshire
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Overview

Job Description

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. BASIC FUNCTIONS: The medical department consists of the Vice President, Medical; Senior Director, Medical Operations; Senior Directors, Medical; Senior Medical Directors and Medical Directors; Medical Data Review Directors; Medical Safety and Data Reviewers; Medical Operation Bidders; and Medical Monitor Operations Specialists. The Senior Director, Medical provides senior medical, clinical and scientific advisory expertise to IQVIA Biotech divisions. In the role of Medical Monitor, the Senior Director, Medical provides medical oversight as the first line of support for clinical trials to which he/she is assigned as medical monitor. As such, the Senior Director, Medical provides medical and scientific oversight of all aspects of Medical involvement on proposed and/or assigned studies including support of pre-award/proposal activities and support to study teams and investigators of awarded studies. The Senior Director, Medical serves as a medical expert throughout business development activities by developing and supporting the medical strategy. The Senior Director, Medical provides management of assigned staff, and provides administrative leadership to the Medical Department by assisting the VP, Medical with delegated roles and responsibilities of managing the daily affairs of the department. Major duties of the Senior Director, Medical are outlined below: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Medical Monitoring: Clinical Activities: * 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 Data Activities: * 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 assistanc

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