Clinical Scientist
Encontrado em: Talent BR C2 - 2 semanas atrás
PURPOSE
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.
RESPONSIBILITIES
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:
o Patient profiles
o Safety listings
o Other data listings, including Efficacy listings
o Coding for Adverse Events (AEs)
o Concomitant medications
o Safety listings review and queries generation, where appropriate
o Protocol Deviations Log review
o Concomitant medications and 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:
o Participate in the preparation of information and summary slides for client mtg
o Manage and track action items from Medical Delivery Services Kick-off mtg
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:
o Investigator meetings
o Protocol training
o CRA training
o Program kick-off meetings
o Disease area research
o Standard of care
o Results from clinical trials in specific indications
Where appropriate, contributes to:
o protocol concept development by providing input to the Medical Writer
o clinical study reports by providing input to the Medical Writer
o clinical sections of Regulatory documents by providing medical team input
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
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)IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at
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