Beijing - Field
Provides leadership to one or more Local Study Teams (LSTs) and provides local strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the local CCO portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers. Principle Accountabilities and Responsibilities: 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. • Sets the LST goals and ensures goals are in line with the operational strategy agreed by Clinical and Study Management Teams. Provides coaching to the team to facilitate the setting and achievement of goals. • Ensures that each team member is aware of his/her specific area of accountability and responsibility within the LST. • Manages and coaches performance of study team members by setting expectations, supporting team members, monitoring performance, providing feedback and following up, when appropriate to ensure performance is optimized. • Liases with other functional groups to ensure the LST(s) members and monitors receive appropriate therapeutic area and study specific training. 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. • Oversees project, protocol, site feasibility and determines site selection and patient allocation (total and annualized) with local CCO and the HQ study (GSL and GSM). • Analyzes results of project, protocol and site feasibility testing, and provides country feedback or recommendations to SMT. In accordance with the overall project plan, establishes and maintains accurate study level plans in PlanSource. • Develops local CCO scenario plans that deliver the studies on time, with the most efficient use of budget and resources. • Develops country/regional level study timelines and ensures that milestones are set and managed for the overall studies delivery in association with the GSM. • Develops and manages local CCO budget/financial plan, and forecasts using appropriate tools, ensures the LST(s) has the appropriate resources to effectively deliver high quality studies on time and within budget. • Responsible for ensuring site level contracts are completed. • Provides input from a country/region perspective into development and implementation of drug management, contracts, budgeting, resourcing, source document verification, data flow, case report forms, and safety monitoring for the local CCO via the GSM. • Provides input on local requirements for biologic sample plan to the Global Biosample Specialist. •In collaboration with the GSM and where necessary, PDQ, develops and executes the local implementation of the audit quality and risk management plans identifying critical issues for the local CCO and ensuring contingencies are established and captured in the study level risk management plan. Ensures that the plans are reviewed and updated over the course of the studies. • Provide
s content review and input into the global communication plan. • Develop
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