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Centralized Monitoring Assistant
1 month ago
Job Summary:
We are seeking a highly skilled Centralized Monitoring Assistant to join our team at IQVIA. As a Centralized Monitoring Assistant, you will play a critical role in supporting the clinical study management team by providing administrative support, managing study trackers, and performing centralized monitoring activities.
Key Responsibilities:
- Provide study-level administrative support to the clinical study management team.
- Manage study trackers, follow-up on outstanding issues, and perform centralized monitoring activities.
- Assist in updating and maintaining systems within project timelines/plans and drive tracking compliance in various systems.
- Perform activities as per the task list delegated by CMS leads.
- Assist in preparing i-site packs for assigned studies and interact with sites/CRA to follow-up on missing data, pending queries, and SDV backlog.
- Establish and maintain effective project/site communication and manage operational insight of assigned sites/studies.
- Perform subject-level data review and study-specific analytics based on applicable study-specific plans.
- Act as a backup for Centralized Monitors/Sr. Centralized Monitors and provide support to the technical solution specialist on formulations in Excel and automations of tools.
Requirements:
- Other Graduate/Post Graduate in Life Sciences or related field.
- Minimum of 2 to 5 years of work experience with minimum of 1 year relevant experience.
- Good knowledge of applicable clinical research regulatory requirements, including International Conference on Harmonisation - Good Clinical Practice and relevant local laws, regulations, and guidelines.
- Proficient in Clinical Systems, including electronic data capture (EDC), interactive X response system (IXRS), clinical trial management system (CTMS) or equivalent systems.
- Experience of managing global phase trials and clinical trial systems and/or reviewing clinical trial data.
- Strong written and verbal communication skills, including good command of English language.
- Results and detail-oriented approach to work delivery and output.
- Good problem-solving skills, planning, time management, and prioritization skills.
- Attention to detail and accuracy in work.
- Good software and computer skills, Microsoft Office applications, including but not limited to Microsoft Word, Excel, and PowerPoint.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Strong telecommunication skills.
- Good data entry skills.
About IQVIA:
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.
