Clinical Scientist Oncology-Hematology CNS Immunology & Internal Medicine

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 crossfunctional 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 timelyprogress and consistency with deliverables associated with medical data review ( 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 underthe 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

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