Clinical Scientist
Buenos Aires, AR
hace 4 días
source : DirectEmployers Association

As a Clinical Scientist you will support medical monitoring and scientific tasks on projects under the guidance of Therapeutic Medical Advisors and in collaboration with various 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 () 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 (, 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 + Bachelor's or 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). 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 prioritiesAt IQVIA, 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.
  • The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

    Learn more at IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward.

    Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.

    Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled

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