The Technical Writer creates and maintains technical documentation, including user guides, reference manuals, and SOPs, while collaborating with IT staff and subject matter experts. They also support business analysis activities by assisting with requirements, release notes, and user acceptance testing plans.
Conduct regulatory audits of COG institutions by reviewing IRB submissions, informed consent documents, audit findings, and site corrections, and prepare and distribute audit reports. Review protocol deviations, early closure requests, and regulatory documents for compliance, coordinate with sites and relevant organizations, and maintain related procedures, templates, and guidance.
Manage and screen clinical trial data, generate computer reports, and conduct statistical analyses for interim monitoring, study reporting, and manuscripts. Support trial design and study committees through statistical planning, reporting, programming, and methodological research.
The Budget Manager will oversee the full portfolio of industry-sponsored trials, including budget development, scope of work negotiation, and financial tracking. They will also collaborate with stakeholders to optimize operational processes, maintain budget records, and provide strategic financial reporting.
