Senior Start-up Specialist

hace 7 días

Buenos Aires, Argentina Labcorp A tiempo completo

Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.
- When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness.
- Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
- Ensure efficient in country execution and local improvements aligned with global requirements.
- Review and approve projections and timelines to study teams, ensuring that they accurately represent the country’s performance and suggests mitigation actions in agreement with SUCM.
- Develop project specific plans for the Site Activation component of assigned studies
- When appropriate, take a lead in team meetings to resolve issues and progress the trial
- Review and approve Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM.
- Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
- Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
- Liaise with Covance regulatory regarding document submission requirements
- Ensure appropriate systems are updated accurately and compliantly, with site information and study dates (projected and actual) ensuring others follow established processes
- Coach other start-up team members
- May take country start up lead role for larger/more complex projects
- Perform other duties as assigned by management

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