IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics 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.
• 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.
• 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:
- Safety listings review and queries generation (where appropriate)
- Protocol Deviations Log review
- 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:
- 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, 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
• 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 (CNS) 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
• 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).
• CNS experience (preferred)
• Extensive use of computer and smart phone keyboards requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
• Regular sitting for extended periods of time.
• Manual dexterity required to operate office equipment (i.e. computers, telephones, smart phones, etc.).
• Occasional travel may be required
-Full time (40 hours per week)
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
Job ID: R1092345