Are you someone with previous regulatory submissions experience looking for developing your career within this area?
At Covance we are recruiting for a SSU Associate Project Manager to work sponsor dedicated into a top 5 pharmaceutical company.
- Assignment of site numbers
- Identification of patients documents required for translation
- Assessment of local sourcing availability of drug
- Start-up timelines estimation
- Oversight and coordination of CTC tasks during validation (support)
- Coordination of collection of site documents required for EC/HA submission
- Local ICF adaptation
- Review and adaptation of patient recruitment and retention materials
- Recruitment materials –
- Cooperation and support of contract/financial team during contracting process
- Providing update to study team members, i.e. CRM, CRAs, RCPM, CTC regarding current start-up status
- Local IMP, drug and non-clinical supplies management
- Coordination of preparation of ITFB