Leading the cross-functional Clinical Study team
- Leading the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices
- Actively track study progress through applicable systems
- Coordinate and drive the ongoing medical / scientific review of the clinical trial data, data analysis and interpretation including the development of first interpretable results and the clinical study report with the CTT
- Co-author of the clinical study protocol, Protocol Amendments and other essential documents (ICF, CRF specifications etc.)
- Train and support the CRA(s) on study protocol and related questions and serve as point of contact for questions relating to trial procedures and subjects’
eligibility
- Lead and man
- Forecasted clinical study team resources and Overall Trial budget
- Coordinated, contributed and secured timely delivery of key clinical study documents (study protocols, protocol amendments, CRF, ICFs, Management plans etc.)
- Defined scope of 3rd Parties and change orders, trained and managed CRO and other 3rd Parties;
- Approved invoices and leveraged financial reconciliation process
- Coordinated and directed the Issue Management process for assigned
