Centralized Monitor Buenos Aires Buenos Aires
Buenos Aires, Buenos Aires, Argentina
hace 2 días
source : Fidanto

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 PURPOSE To provide project related support and assistance across multiple projects sites and teams and Review the structured clinical data output with access to medical charts To ensure the work is conducted as per SOPs Policies and Good clinical practice s and applicable regulatory requirements Adherence to protocol overall completeness and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines RESPONSIBILITIES 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 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 studiy 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 Central Monitor May perform Subject Level Data Review that require further investigation with the clinical site to determine overall accuracy inclusion exclusion criteria IP AE Labs EOT EOS End points SAEs etc Review any other information as necessary to determine overall readiness of the patient information for next level review May Act as back up for Sr Central Monitor REQUIRED KNOWLEDGE SKILLS AND ABILITIES Advanced knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements i e ICH GCP and relevant local laws regulations and guidelines towards clinical trial conduct Familiarity with related systems and software utilized in clinical operations Strong written and verbal communication skills including good command of English language Results and detail oriented approach to work delivery and output Ability to work on multiple projects and manage competing priorities Ability to establish and maintain effective working relationships with coworkers managers and clients Good planning time management and prioritization skills Good software and computer skills including MS Office applications including but not limited to Microsoft Word Excel and PowerPoint Ability to work across cultures and geographies with a high awareness and understanding of cultural differences MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor s degree in clinical life sciences mathematical sciences or related field or nursing qualification with 1 years of relevant work experience or equivalent combination of education training and experience Join Us 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 R1121360

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