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Country Study Specialist & Study Start-up Specialist (Kuwait)
الوصف الوظيفي
CSS “Country Study Specialist” Role:
Objectives and Scope of Position
The Clinical Operations Hub Country Study Specialist (CSS) is responsible for providing project coordination and operational solutions to support Clinical Operations Hub Country Study Managers (CSMs).
The position also provides clinical trial oversight to local study teams to enable effective management of both global and local trials.
Main Responsibilities and Accountabilities:
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, and budget plans and provides oversight for site payments per contract, as required.
Manages shared study areas (e.g. TouchPoint), according to Roche standards.
Responsible for ordering study-related supplies/IMP and non-IMP, as delegated by the role supported, and as required.
Maintains effective and ongoing communication with CSM; supports communication with local study teams and to sites as required.
Works with the global study team and CSM to 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 coordination and oversight of hub/country level audit/inspection action plan activities.
Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance.
Coordinates study or country communication plan.
In collaboration with CSM, responsible for vendors/contracts management during the study conduct.
Patient Journey Partner (Kuwait)
الوصف الوظيفي
The Position
The Patient Journey Partner (PJP) is at the center of the new Roche organization, turning upside down the role we play in society - from mostly offering world-class medicines towards much more partnering, innovating and leading generative disruption. By doing so the PJP will be directly accountable to deliver better outcomes for patients, their community, the ecosystem and the organisation, faster.
The PJP is an empowered leader and the local face of Roche. It collaborates closely with all stakeholders directly touching the patient journey (in a given therapeutic or disease area), gaining a deep understanding of their needs in order to connect Roche’s capabilities to co-create meaningful solutions.
This role is locally embedded in the ecosystem, is an integrated role, functionally agnostic, (i.e. it does not fit into the traditional concepts of Commercial/Sales or Medical Affairs), and it has no profitability, sales objectives or incentives.
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