IQVIA™ is The Human Data Science Company™, focused on using data
and science to help healthcare clients find better solutions for
their patients. Formed through the merger of IMS Health and
Quintiles, IQVIA offers a broad range of solutions that harness
advances in healthcare information, technology, analytics and human
ingenuity to drive healthcare forward.
The Clinical Scientist supports medical monitoring and scientific tasks on projects under the guidance of Therapeutic Medical Advisors (TMA) and in collaboration with the 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.
• 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 (e.g. summary of clinical trial data) 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 (e.g. preparation of files, 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 training
• CRA training
• 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 proposals and bid defenses, such as:
• review protocols with the assigned TMA
• gather and summarize data from scientific literature
• review and input to the project medical services budget
• Assist with protocol development and review for early engagement/partnership programs.
• Contribute to Medical Strategy and Science and other initiatives that support the advancement of Quintiles’ therapeutic capabilities