Sachbearbeiter:in Compliance Office bei PostFinance, verantwortet Compliance - relevante Fälle und Anliegen aus der Teammailbox. Abwechslungsreiche Aufgaben in einem hybriden Arbeitsumfeld in Bern mit Homeoffice - Option.
About the role
- Regulatory Technician working with Clinical Trials Information System at ICON plc in Mexico. Supports regulatory submissions, data management, and collaboration with stakeholders.
Responsibilities
- Work with the Clinical Trials Information System (CTIS)
- Provide support for submissions and other documents by performing necessary tasks including assembly, dispatch among others and coordinating resources for submissions.
- Proactively identify and mitigate risks through CTIS helpdesks regarding data/document management and upload to CTIS and liaise with internal/external stakeholders to resolve
- Actively maintain applicable study-level account access for assigned projects for CTIS to maintain compliance and confidentiality
- Collaborate with key stakeholders to manage and perform data entry and document upload
- Monitor CTIS notifying applicable stakeholders of activities for their action and subsequent follow up
- Create files documenting submissions completed through CTIS, conclusions, decisions and any other communication provided via CTIS
- Perform Quality Control review in accordance with applicable process
- Maintain agreed timelines
- Ensure project-specific training is completed on time, as applicable
Requirements
- Minimum 3 years of relevant experience within clinical research and have knowledge of clinical terminology and documentation
- Advanced expertise of applicable Clinical Trial Regulatory system/portal
- Mandatory advanced English (speak, read, write)
- Ability to work independently
- Experience with regulatory submissions and CTIS is a differential but not mandatory
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
Location requirements
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