长沙招聘

工作职责:

? 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 (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.

? Maintains effective and ongoing communication with CSM;supports communication with local study teams and to sites as required.

? Works with global study team and CSMto manage or support the day-to-day activities of the study. including monitoring reports review. problem solving. issue escalation. timely closure of non-productive sites and tracking of safety procedures.

? Supports management of country-level Trial Master File (TMF)and reviews for quality (including translations. as applicable).

? 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 CSMon CRAs.and local supplier/vendor performance.

? Coordinates study or country communication plan.

任职资格:

? University degree or equivalent; professional qualification preferably in a medical/SCience-related field and experience demonstrating knowledge and understanding of clinical trials.

Monitoring experience is desirable.

Previous experience managing projects is desirable.

? Managing Work - effectively manages self-time and resources to ensure that work is completed efficiently.

? Monitoring Information - sets up ongoing procedures to collect and review information needed to manage an organization or ongoing activities within it.

? Communication - conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.

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