- Gather Study Set up requirements through discussion and communication with relevant stakeholders.
- Perform Database Set up and validation to ensure quality study design for data collection.
- Support validation of new Device integrations.
- Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor.
- Ensure that all the deliverables are of expected quality standards and meet customer expectations.
- Support Training of New joiners.
- Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings.
- Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended by DTL.
- Manage the development and implementation of new technology / database revisions.
- Work closely with the programming team for process innovation and automation.
- Be compliant to trainings and eSOP reading.
- Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
- Communication with Line Manager, Leadership and other team members across functions should be collaborative.
- Bachelor's degree or educational equivalence in clinical, biological or mathematical sciences or related field OR a nursing qualification or equivalent combination of education, training and experience.
- Robust understanding of medical terminology and jargon required.
- At least 3 years of relevant experience in clinical data management.
- Strong EDC experience in clinical trials coupled with DM queries (familiarity with EDC platforms).
- SAS experience is not required, although good to have (database design).
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Associate Clinical Data Manager - North Sydney, Australia - IQVIA
Description
Responsibilities:
Skills and experience required:
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. Learn more at