Resultados de la búsqueda: 13 vacantes
...datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned...
...Safety Submissions team if contracted to submit the reports.
Participate in audits/inspections as required.
Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance...
...belong.
Job responsibilities
• Monitor and route incoming information to the appropriate project
• Records all ICSR documentation and tracks in accordance with Sponsor/customer specifications; distributes incoming mail and faxes.
• Redacts patient...
...institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• May lead (with supervision) multi-... ..., and ensures that corrections are appropriately made and documented.
• Provides supports to business development and...
$71,820 - $139,600 por año
...o Understands applicable local, national, and regional regulations and translates them into organizational best practices.
o Documents the interpretation in a standardized format within the Regulatory Intelligence System in line with implemented procedures and business...
...regulations, and company SOPs/processes.
Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient...
...rules and access controls.
· Perform database migrations, upgrades, and patching as required.
· Develop and maintain technical documentation including data models, schema diagrams, and standard operating procedures.
· Stay up-to-date with the latest Oracle...
...rules and access controls.
· Perform database migrations, upgrades, and patching as required.
· Develop and maintain technical documentation including data models, schema diagrams, and standard operating procedures.
· Stay up to date with the latest Oracle...
...-end tests to validate created test cases
-Evaluate issues discovered and report confirmed issues with sprint teams
-Maintain documents related to automation testing (testing procedures, coding standards, how to's, etc.)
-Configure and run automated tests as schedules...
...sponsors, auditors, regulatory inspectors or other external parties.
Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content. May be assigned to support quality-related...
...contracts, ethics and regulatory submissions, and of
essential documents required for site initiation. Ensures local activities are... ...start-up on allocated projects. Compiles and/or reviews essential document
packages for site activation and may also be involved in...
...regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/...
...issues.
• Immediately communicates/escalates serious issues to the project team and with guidance develops action plans.
• Documents observations noted during reviews and writes queries, protocol deviations or action items as necessary in appropriate systems for...
