As a Clinical Scientist you will support medical monitoring and scientific tasks on projects under the guidance of Therapeutic Medical Advisors and in collaboration with various cross-functional project team.
These activities enable the use of high quality, scientific data to make timely decisions during clinical study planning, execution, analysis and reporting.
This includes CRA / investigative site support as well as advanced safety and data analytics. Essential Functions + Respond to protocol questions / CRAs / Sites under direction and supervision of the global study TMA.
Collaborate with the Medical and Safety Data Review teams to ensure timely progress and consistency with deliverables associated with medical data review () and where appropriate review of : - Patient profiles - Safety listings, other Data listings including Efficacy listings - Coding for Adverse Events (AEs) and concomitant medications+ Participate in the preparation of medical monitoring plans in collaboration with Drug Safety and Medical Data Review teams.
Support project budget reviews.+ Prepare for and where required attend Safety review meetings with Sponsors under the supervision of the global Medical Advisor and the Medical Safety physician, covering areas such as : - Safety listings review and queries generation where appropriate - Protocol Deviations Log review - Concomitant medications & coding+ Coordinate activities and 'flow of information' with Medical Safety Advisor, Medical Data Reviewer and Medical Surveillance Specialist during study start up and throughout the project lifecycle, such as : - Participate in the preparation of information and summary slides for client meetings- Manage and track action items from Medical Delivery Services Kick-off Meetings (KOMs)+ Support quality assurance and other audits that involve the review of medical services (, tracking and management of audit follow up actions and preventatives).
Conduct electronic Trial Master File (eTMF) maintenance in relation to Medical and Scientific Services activities.+ Prepare and deliver presentation materials under the supervision and review of the global TMA, such as : - Investigator meetings- Protocol and / or CRA training - Audits - Program kick-off meetings+ Perform literature searches and summarize data / information including : - Disease area research- Standard of care - Results from clinical trials in specific indications+ Where appropriate, contributes to : - Protocol concept development by providing input to the Medical Writer- Clinical study reports by providing input to the Medical Writer - Clinical sections of Regulatory documents by providing medical team input+ Assist with protocol development and review for early engagement / partnership programs.
Qualifications + Bachelor's or Master's degree in a biomedical, life science or similar scientific field+ 3 years of clinical trial experience, including 2 years of directly relevant therapeutic area(s) experience.
Advanced scientific degree preferred (PhD, PharmD). Required Knowledge, Skills and Abilities + Understanding of relevant therapeutic area+ Understanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Knowledge and experience to conduct activities in compliance with regional / global regulatory requirements+ Understanding of clinical trial design and execution+ Good communication, interpersonal, negotiating and reporting skills+ Demonstrated proficiency in using systems and technologies to achieve work objectives+ Medical / clinical knowledge to independently review adverse event data.
Ability to work on and collaborate with colleagues on global teams+ Ability to proactively predict issues and solve problems+ Ability to positively influence internal and external stakeholders, including internal global and matrix teams.
Ability to balance multiple prioritiesAt 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 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.
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