Clinical Scientist - Homebased In Europe
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Clinical Scientist - Homebased In Europe

София длъжност на пълно работно време

За нас

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.


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.



• 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 training
• 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 proposals and bid defenses, such as:
• review protocols with the assigned TMA
• gather and summarize data from scientific literature
• review and input to the project medical services budget
• Assist with protocol development and review for early engagement/partnership programs.
• Contribute to Medical Strategy and Science and other initiatives that support the advancement of Quintiles’ therapeutic capabilities

Изисквания и необходими умения


• Fluent English writen and spoken
• 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

• Master's degree or PhD in a biomedical, life sciences or similar scientific field and 5 years of clinical research experience including 2 years of directly relevant therapeutic area(s) experience; or equivalent combination of education, training and experience

Ние Ви предлагаме

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.

Job ID: R1045630