Vaga de Clinical Scientist
1 vaga: | Publicada em 25/04
- A Combinar
Sobre a vaga
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
Participate in the preparation of medical monitoring plans in collaboration with
Drug Safety and Medical Data Review teams.
Respond to protocol questions/CRAs/Sites under direction and supervision of the
global study TMA.
Collaborate with Project Leads and Contract Analysts to review and finalize the
contract/budget and future COs.
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:
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
Perform literature searches and summarize data/information including:
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
Contribute to Medical and Scientific Services and other initiatives that support
the advancement of IQVIA therapeutic capabilities
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 priorities
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Masters 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
https://jobs.iqvia.com