Coordinates/supports operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring Roche quality and safety standards, regulations, timelines and budget commitments are met.
Performs/coordinates protocol and site level feasibility activities, including evaluation of patient population and final site selection reflected in site feasibility report (if applicable).
Provides input into and /or develops study related materials such as monitoring plans, recruitment plans and study newsletters.
Supports/coordinates the negotiation of site budgets within fair market value (FMV) guidelines, budget plans and provides oversight for site payments per contract, as required.
Supports/Coordinate the site specific documents such as ICF, contract for internal review and approval
Supports/coordinates the SMT meeting, follows up the meeting minutes record and issues resolution.
Maintains effective and ongoing communication with CPL; supports communication with SMT (Study Management Team) and to sites as required.
Works with CPL and/or ICTM to manage or support the day-to-day activities of study, including EC dossier preparation and study regular trackings, site initiation activities, oversight monitoring status and SMR review, issues and solution tracking, timely and properly issue escalation and tracking of safety distribution/ reconciliation.
Supports management of study/country-level (e)TMF tracking, and reviews for quality (including translations, as applicable),follows up the issues identified until resolution.
Is responsible for the co-ordination and oversight of local affiliate study level audit/inspection audit action plan activities.
Provides feedback to local vendor manager and CPL on CRAs, and local supplier/vendor performance.
Delivers the study specific training to FSP CRA or CRO personnel if required.
Coordinates study or country communication plan.
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