长沙招聘

工作职责:

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 (FMVJ 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 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 co-ordination and oversight of local affiliate study level audit/ inspection audit action plan activities.

? Provides feedback to local vendor manager and CSM on CRAs, and local supplier/vendor performance.

? Coordinates study or country communication plan.

任职资格:

Qualifications:

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.

Competencies:

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.?

Work Standards 一 sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed.

Adaptability - maintains effectiveness when experiencing major changes in work responsibilities or environment (e.g., people, processes, structure, or culture

; adjusts effectively to change by exploring the benefits, trying new approaches, and collaborating with others to make the change successful.

Building Partnerships - develops and leverages relationships within and across work groups to achieve results.

Initiating Action - takes prompt action to accomplish work goals; takes action to achieve results beyond what is required; is proactive.

Earning Trust 一 gains others

confidence by acting with integrity and following through on commitments while disclosing own positions; treats others and their ideas with respect and supports them in the face of challenges.

Decision Making-identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and makes timely decisions; takes action that is consistent with available facts and constraints and optimizes probable consequences.

Influencing - uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.

Technical/Professional Knowledge and Skills 一 has achieved a satisfactory level of technical, functional, and/or professional skill or knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.

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