Country Study Manager

China, Shanghai, Shanghai
China, Beijing, Beijing

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Provides Direction and Leadership to one or more LSTs:

  • Builds effective, high performing LSTs through influence, integration, motivation and optimization of team performance. Embeds the Roche values into the team(s) culture and promotes the team spirit.
  • Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, e.g. Pharma Business, GSM, functional management.
  • Represents the LST(s) at the SMT.
  • Maintain awareness of external clinical research practices to ensure the LST(s) and monitors are aware of the risks, priorities, value and impact of their work and contributions.

Establishes Study Timelines, Budget, Resource, Risk and Quality Plans:

  • Provides the GSM with feedback from the local CCO perspective into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.
  • In accordance with the overall project plan, establishes and maintains accurate study level plans in PlanSource.
  • Is accountable for the development and active management of the study patient recruitment strategies in the local CCO.
  • Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.
  • Is accountable for the selection, training and management of external suppliers supporting the local CCO.

Manages the Delivery of Study Activities in Order to Meet Study Plans:

  • Is accountable for all local CCO regulatory, ethical and administrative submissions.
  • Ensures that data is delivered in accordance with established dataflow timelines.
  • Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in local CCO Investigator Meetings as necessary.
  • Implements the country-level recruitment plan.
  • Monitors progress against LST goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.
  • Oversees the management of the local CCO studies budget.

Identify Areas of Best Practice and Process Improvements:

  • Leads the evaluation of standards across one or more LST(s) with the objective of enhancing quality, productivity and efficiency.
  • Contributes to activities to improve and maintain the quality and effectiveness of processes and activities within the function.
  • Makes an active contribution to therapeutic area strategy teams (e.g. Oncology Franchise Network) ensuring knowledge shared locally and globally.
  • Takes ownership for own development.