Associate

• Perform activities pertaining to Phase I–III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and relevant procedures and guidelines
• Perform ongoing data review
• Reconcile third-party data streams
• Reconcile serious adverse events with the safety database
• Perform User Acceptance Testing (UAT) of clinical databases
• Perform Quality Control (QC) of clinical databases
• Perform ongoing updates of Data Management-related documentation

Senior Clinical Data Associate supporting clinical trials for Syneos Health’s biopharmaceutical clients

Senior Clinical Data Associate

Senior Clinical Data Associate supporting Phase I–III clinical trials for Syneos Health’s biopharmaceutical clients. Reviewing and validating clinical data, databases, and safety reconciliations.

• Support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities.
• Develop simple investigator grant estimates and proposal text to support the proposal development process.
• Utilize and maintain contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration, including communication with sponsors, stakeholders, and RSU regions and countries, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
• Provide specialist operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Assist in the creation and/or review of core scientific, technical, and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Contribute to the collection, interpretation, analysis, and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
• Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
• Comply with contract management and quality standards.
• Provide administrative and operational support to investigator site contract analysts, managers, and directors as required.
• Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.

Senior Site Contract Associate supporting clinical development at IQVIA Biotech

Senior Site Contract Associate

Senior Site Contract Associate at IQVIA Biotech handling contracting activities for clinical development across multiple studies and sponsors.

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Senior Clinical Data Associate

Senior Site Contract Associate