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 a Chief Medical Officer, Medical Directors, medical writers, and safety associates.
The Senior Medical Director provides medical and scientific support to clinical research programs, study teams and investigators.
The Senior Medical Director also provides review, advice, and leadership for potentially or actually awarded clinical research programs.
The Senior Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams.
The primary role of Senior Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies.
The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team.
The Medical Monitor is customarily available 24 / 7 to answer questions from site coordinators and investigators on protocol inclusion / exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference.
Major duties of the Medical Director are outlined below : ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES : + Functions as project team member + Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and / or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reporting + Ensures medical activities run according to GCP and operate with highest efficiency + Establishes and maintains a network of medical / scientific consultants, etc.
Interacts with key thought leaders and / or sponsor representatives to develop inclusion / exclusion criteria and study endpoints.
Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.
Aids in review and final selection. + Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and / or participation in teleconference and WebEx presentations + Presents protocol and / or safety reporting information at investigator meetings + Develops project medical monitoring plans as requested + Provides on call coverage for protocol queries and site support.
Provides first line contact for investigators and monitors regarding study related medical / safety issues and resolution of study protocol and patient eligibility issues.
Safety Monitoring and SAE Reporting Activities : + Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study + Provides medical review of SAE reporting, writes and / or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed + Reviews IND / SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data + In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.
e. breaking the blind) + Interact with appropriate FDA officials concerning safety and other study related issues, as requested Data Activities : + Provides medical review of eCRFs for clinical accuracy + Provides medical review of data analysis plan + Reviews safety fields at case freeze for reconciliation (if needed) + Works with data group to reconcile SAE events as needed + Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends + Reviews data tables, listings, and figures + Reviews and / or writes portions of final clinical study report DSMB / Adjudication Committee Activities :
It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning. At IQVIA, we have a vision. Where every healthcare decision is based on evidence.
Where data science and human science come together to improve global health. Where new and creative solutions aren't just possible - they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare.
The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease.
We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you're supported to succeed.
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