Operations Specialist 1

Posted:
9/17/2024, 1:56:25 AM

Location(s):
Community of Madrid, Spain ⋅ Madrid, Community of Madrid, Spain

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Medical, Clinical & Veterinary

Job Overview
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.

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 (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 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
• Other  Advanced degree, PhD or PharmD Pref
• Master's Degree Master’s degree, advanced nursing, or other degree in a biomedical, life science or similar scientific field with relevant work experience will also be considered Req
• 3+ years of experience in clinical science, clinical research, or equivalent, including 2 years of directly relevant therapeutic area(s) experience  Req
• • 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
• Understanding of functional and cross-functional relationships, and ability to work on and
collaborate with colleagues on global teams
• Ability to positively influence internal and external stakeholders, including internal global 
and matrix teams
• Proficient critical thinking, problem-solving, decision-making skills
• Proficient knowledge and skills to support data review activities, trend identification, 
data interpretation
• Excellent verbal, written, communication and interpersonal skills
• Medical/clinical knowledge to independently review adverse event/safety data
• Ability to proactively predict issues and solve problems
• Adaptable and flexible and able to adjust to multiple demands and shifting priorities as 
well as meet day-to-day challenges with confidence and professionalism
• Demonstrated proficiency in using systems and technologies to achieve work objectives 
(e.g., Microsoft Word, Excel, PowerPoint, Electronic Data Capture, etc.)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com