Head of Clinical Operations - China

China, Shanghai, Shanghai

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Strategic Direction:

  • Develops the strategy and drives implementation of local tactics for CCO China to meet both long-term and annual goals as cascaded from global function(s) and in alignment with PD SH and China affiliate.
  • Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline.
  • Identifies and implements strategies and tactics to ensure continuous productivity and efficiency gains, and a high performing clinical operations team.
  • Provides input and/or drives the prioritization exercise (planning phase) of the PD SH plan as well as local Affiliate Medical Plan.
  • Accountable for ensuring departmental budget is well managed.
  • Ensures “best practice” in all activities, effective implementation and optimization of global/regional/local process improvements.
  • Contributes to global and local initiatives aimed at increasing quality and delivery of clinical operations activities (both globally and locally).

Country Study Management:

  • Accountable for the execution of all data-generating activities (studies) conducted by CCO China, including all Roche sponsored and supported, interventional and non-interventional trials. Accountable to ensure that execution of these studies are compliant to ICH/GCP & GPP standards, Roche SOPs, local operating guidelines and local requirements including legal and financial standards and practices.
  • Accountable for the establishment and effective operation of Local Study Management Teams including support and collaboration with PD SH and all China affiliate departments to share information about the nature of studies being conducted in the Country.
  • Accountable for setting up and maintaining an effective local FSP (Functional Service Provider) governance model to ensure overall study commitments, KPIs and provision of adequate resource in line with FTE demand projections (such as CRA/CTA) are met and that issues are escalated appropriately.
  • Accountable for oversight of any local contracts put in place for studies managed by CCO China.
  • Accountable for meeting country study commitments, in line with agreed country goals (budget, quality, patient recruitment and timelines).  In the event that study commitments are not going to be met, ensures timely discussions are held with the study project team (global or local) and mitigating actions put in place.

People Management:

  • Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture.
  • Accountable for resource management, performance management and career development of CCO China staff.
  • Actively participate in PD SH and China affiliate HR activities to support and profile the Department at the local level (benchmarking etc).
     

Stakeholder Management:

  • Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with Roche policies and country legislation.

Develops and maintains excellent relationships and interactions between the Clinical Operations team, Medical department, and other global, regional and local functions.

Strategic Direction:

  • Develops the strategy and drives implementation of local tactics for CCO China to meet both long-term and annual goals as cascaded from global function(s) and in alignment with PD SH and China affiliate.
  • Proactively implements measures to ensure the effective delivery of clinical studies, including preparation for the conduct of studies in existing and new Therapeutic Areas, as required by the development pipeline.
  • Identifies and implements strategies and tactics to ensure continuous productivity and efficiency gains, and a high performing clinical operations team.
  • Provides input and/or drives the prioritization exercise (planning phase) of the PD SH plan as well as local Affiliate Medical Plan.
  • Accountable for ensuring departmental budget is well managed.
  • Ensures “best practice” in all activities, effective implementation and optimization of global/regional/local process improvements.
  • Contributes to global and local initiatives aimed at increasing quality and delivery of clinical operations activities (both globally and locally).

Country Study Management:

  • Accountable for the execution of all data-generating activities (studies) conducted by CCO China, including all Roche sponsored and supported, interventional and non-interventional trials. Accountable to ensure that execution of these studies are compliant to ICH/GCP & GPP standards, Roche SOPs, local operating guidelines and local requirements including legal and financial standards and practices.
  • Accountable for the establishment and effective operation of Local Study Management Teams including support and collaboration with PD SH and all China affiliate departments to share information about the nature of studies being conducted in the Country.
  • Accountable for setting up and maintaining an effective local FSP (Functional Service Provider) governance model to ensure overall study commitments, KPIs and provision of adequate resource in line with FTE demand projections (such as CRA/CTA) are met and that issues are escalated appropriately.
  • Accountable for oversight of any local contracts put in place for studies managed by CCO China.
  • Accountable for meeting country study commitments, in line with agreed country goals (budget, quality, patient recruitment and timelines).  In the event that study commitments are not going to be met, ensures timely discussions are held with the study project team (global or local) and mitigating actions put in place.

People Management:

  • Develops a highly motivated team through effective leadership, coaching and people management, ensuring an objective and performance-led management culture.
  • Accountable for resource management, performance management and career development of CCO China staff.
  • Actively participate in PD SH and China affiliate HR activities to support and profile the Department at the local level (benchmarking etc).
     

Stakeholder Management:

  • Ensures effective collaboration either directly or through others with investigators, ethics committees, clinical research networks, patient groups and, as required, local Health Authorities, in compliance with Roche policies and country legislation.
  • Develops and maintains excellent relationships and interactions between the Clinical Operations team, Medical department, and other global, regional and local functions.

Who you are

  • Competencies
  • Strategic Agility – able to articulate, long-term strategies and objectives and provide clarity and focus on key priorities.
  • Decision Making – able to make sound decisions even in the face of ambiguous circumstances or contradictory requirements
  • Teamwork and Collaboration – successful and comfortable working in a complex international matrix, able to seek common ground in an effort to resolve conflicts, able to pull people together around a common goal, and to build diverse teams leveraging them to deliver exceptional results.
  • Change Management – able to effectively manage change, explaining the context, answering questions and listening to concerns, to introduce needed change even in the face of opposition.
  • Communication – able to clearly articulate complex concepts and encourages direct and open discussions about important issues.
  • Personal Organization – highly organized with excellent ability to prioritize and manage multiple tasks, is self-motivated and achievement/results driven for themselves and for others.
  • Cost and financial awareness – good judgment in relation to trade-offs between cost and effectiveness.
  • Technical and Business Expertise – ability to identify opportunities to streamline and improve business operations, to build alliances with internal and external customers that strengthen reputation and create value and has a good understanding of external conditions affecting the local and/or regional organization.
  • Demonstrated ability to implement the Pharma Leadership Commitments
  • B. Knowledge

  • Comprehensive knowledge of ICH GCP, local regulations and all aspects of clinical operational management.
  • Clear and accurate communication in written and spoken Chinese as well as English.
  • Familiarity with the therapeutic areas that are priorities for Roche
  • C. Experience

  • Extensive (~10 years) experience of all phases of clinical development, preferably in more than one major R&D-based pharma company or large CRO or consulting firm.
  • Successful track record working in a complex environment, managing multiple tasks and competing priorities simultaneously.
  • Experience of line management of groups, including managing through managers   and leading high-performing multi-functional study teams.
  • Demonstrated success working with global/regional/local cross-functional colleagues and good understanding of global/local functional/business needs.
  • Proven record of outstanding communication, change management and organizational skills.
  • Demonstrated ability to interact with different professional levels of the external clinical research community.
  • Solid track record of selection and management of CROs and other vendors as applicable.
  • Demonstrated success in setting and delivering departmental goals and managing performance through reliable business indicators.