Job Overview

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.

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 (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 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

• Strong scientific background, PhD or PharmD preferred, advanced nursing or other advanced biomedical degree with post-graduate training and/or relevant work experience.
• Minimum 5 years of clinical trial experience, including a high-skill level of data analysis interpretation.
• Master 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 will also be considered.
• English language on business communication level (C1)
• Experience with the following therapeutic areas: Oncology, Neurology, CNS, Internal Medicine

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.