IQVIA
Clinical Scientist - Homebased In Europe
Sofia
full-time

Clinical Scientist - Homebased In Europe

Sofia full-time

About us

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.

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

RESPONSIBILITIES

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

Requirements and necessary skills

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

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


MINIMUM REQUIRED EDUCATION AND EXPERIENCE
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

We offer

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
Zaplatomer.bg