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
- Study Start Up Associate II at ICON facilitating regulatory submissions and study progress for clinical trials. Collaborating with diverse teams to maintain regulatory compliance and document approvals.
Responsibilities
- Lead regulatory submissions that enable trials to start on time – Prepare and submit clinical trial applications, ethics committee submissions, and communications with regulatory authorities, ensuring every study begins with the highest standards of compliance and integrity.
- Coordinate across teams and stakeholders to unlock study progress – Liaise with internal colleagues and external partners to secure approvals and authorizations, keeping studies on track and supporting patient access to innovative treatments.
- Ensure transparency and accuracy in all regulatory records – Maintain comprehensive documentation of submissions, approvals, and correspondence so that study decisions are informed, traceable, and compliant with global and local regulations.
- Empower study teams with regulatory expertise – Provide guidance and support on study start-up requirements, helping colleagues navigate complex regulatory processes efficiently and effectively.
- Drive process improvements that accelerate research – Identify opportunities to optimize start-up workflows, enhancing efficiency and contributing to ICON’s culture of quality and innovation.
Requirements
- Bachelor’s degree in Life Sciences or a related field.
- Minimum 2 years of experience in clinical research or regulatory affairs, with hands-on experience in study start-up submissions.
- Strong knowledge of ICH-GCP and local regulatory requirements.
- Fluent in English and one additional European language: German, Czech, or Dutch.
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.
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