Centralized Monitor - Dutch SpeakingAre you:Someone who understands dynamics of working with the sites?Results driven and detail-oriented?Good at supporting others on problem solving?Good at planning, time management and prioritization?Skilled at software and computer use, that enjoys technology applied to data analysis?Understands clinical trial conduct, and skill in applying applicable clinical research regulatory requirements and relevant local laws, regulations and guidelines?Able to communicate efficiently and work well across cultures and geographies?Can you speak, read and write Dutch?If you have answered 'yes' to any of the above questions, you might be the Centralized Monitor that we are looking for!What is a Centralized Monitor?A Centralized Monitor (CM) is a key skilled and clinically experienced team member of IQVIA Centralized Monitoring Department. A CM provides remote project support and assistance across multiple projects, sites and teams and reviews the structured clinical data output with access to medical charts.What are the responsibilities of a CM?Perform centralized monitoring activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines.Ensure accurate completion and maintenance of internal systems, databases, tracking tools/reports for the project specific information.May perform Management of triggers and preparation of i-site pack for respective sites and countries for assigned study(ies).May assist in Developing required basic data analytics scope and performing the trend analytics for their respective study(ies).May participate in (study) team meetings and interaction with cross functional staff to verify information and/or triage new data issues or prior identified action items.Escalate quality issues pertaining to site to respective Centralized Monitoring Lead / Sr. Centralized Monitor.May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy.Review any other information as necessary to determine overall readiness of the patient information for next level review.Interaction with sites/CRA and follow-up on study required milestones from the project start until close out.Do you need experience or a degree to apply for this position?You must have a Bachelor's degree in life sciences or related field.At least 1 year experience in clinical research field preferred.Fluency in Afrikaans and English is essential.Must be able to speak, read and write Dutch.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
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