Works closely with the core and extended study teams at every stage of the clinical trial. During study set up he/she ensures well-defined standards are outlined and appropriate eCRF modules and Safety Monitoring agreements are in place. During the recruitment and maintenance phases of the clinical trial, he/she uses the  data review tool to review and query important clinical/safety data within the scope agreed with Medical team and documented accordingly.

Responsibilities
• Ensure consistent processes and efficient review of critical clinical/safety data
• Review of patient-level clinical/safety data on an ongoing basis to ensure medical accuracy and completeness, coding consistency and generate applicable queries as needed to obtain information for appropriate medical assessment and case closure
• Prepare aggregated data visualization and facilitate meetings related to review of safety data on study level
• Contribute to study start-up activities according to the applicable process/procedures (ex. input to the applicable documents, tools set up)
• Serve as a member of the Extended Study Team and report on TRISARC deliverables
• Work with the study physicians and/or clinical/project scientists to support standardized high-level data review and medical evaluation
• Escalate urgent and critical medical cases to the study physician/medical scientist as appropriate
• Provide input into the process of setting automated patient narratives, if applicable
• Provide input to establishing the process for handwritten patient narratives, including guideline development and the quality control process if applicable
• Lead quality of own deliverables
• Take on tasks as assigned by the Directors, Associate Directors Clinical Trial Safety
• Provide input into non-drug project work including training activities, continuous improvement and development of procedures as needed

Education/Experience

• Educational degree (BSc/Msc/PhD) in Life Science or equivalent work experience in directly related fields
(preferably medicine, pharmacy, veterinary, biotechnology, nurse, dentist)
• Experience using data review tools such as JReview, JMP Clinical, or Spotfire, EDC
• Understanding of the clinical study and drug development process
• Knowledge of ICH/GCP Guidelines
• Knowledge of SAE reporting requirements
• Quality focus, analytical skills, and ability to concisely summarize large amounts of complex information
• Proven ability to prioritize and manage multiple tasks with conflicting deadlines
• Excellent time management
• Very good interpersonal and communication skills
• Team player, able to work individually
• Ability and willingness to work cross-functionally, e.g. with internal and external partners, on global studies, across different phases of drug development or different therapy areas

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