Protocol Manager||プロトコールマネジャー

Job Description


Establishes and analyzes protocol (Project)-level budget and grants throughout the lifecycle of the protocol. 

Manages clinical components of vendor selection working with Procurement and Outsourcing Management and acts as a central point of contact for communication between the team and the external partners (e.g. CRO, central labs, cooperative groups, alliance partners etc.).

Provides leadership to multi-functional Protocol team. Drives and monitors protocol-related activities throughout the lifecycle of the project ensuring targets are met according to timelines and quality expectations. Serves as the operational subject matter expert for the Protocol.

 Aligns protocol team with organizational goals and objectives of the Japan Development Team, Japan Operations Team, Data Team and Protocol Team and takes actions to achieve them. Develops and implements broad strategies with cross functional input to meet protocol deliverables. Makes critical choices within the context of the assigned protocol that support the strategy of the drug program.

Drives Protocol development process for Japan regional Phase 1 to 4 studies which are conducted in the aim of New Drug Applications (NDAs) and supplemental NDAs (s-NDAs). Provides, clinical, scientific and operational input in protocol (rationale, objectives, design), case report form and other key protocol documents and activities. 

Collaborates with stakeholders to drive cost disciplined science by reducing the operational complexity of the protocol. Identifies opportunities for process improvement and reduction in low-value added activities.

Leads the cross-functional protocol team through start-up activities including study/site budgets and contracts, site identification, feasibility, selection) and site protocol approvals (MOH, IRB/EC). Contributes to clinical supply forecasting and oversight.

Uses Project Management Framework and clinical trial management systems to track metrics, timelines, and other data to assure Protocol quality, timelines and budget are managed according to expectations.

Facilitates identification and prompt escalation of project risks and issues to appropriate stakeholders and/or functional management, to expedite resolution. Proactively analyzes and drives efficient problem solving within team’s control. Applies critical thinking to manage complex issues,

Demonstrates thorough knowledge of relevant SOPs and policies and the ability to provide timely guidance in their application to Protocol teams. Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to protocol management and program strategy.

Effectively leads team in collating information for Operational Reviews, highlighting issues and risks, developing mitigation and resolution strategies, and promptly responding to action items.

Establishes and analyzes protocol-level budget and grants throughout the lifecycle of the protocol. Communicates costs of potential operational and procedural changes to protocol, to team leadership, stakeholders, and senior management.

Applies clinical and scientific knowledge to prioritize the clinical data review and cleaning. Demonstrates a strong understanding of clinical safety and efficacy data.

Drives and motivates the protocol team through operational, project, business, and organizational change.

May oversee set up and operation of DMBs, adjudication boards and other committees in support of protocol level strategies. 

Manages clinical components of vendor selection working with Procurement and Outsourcing Management and acts as a central point of contact for communication between the team and the external partners (e.g. CRO, central labs, cooperative groups, alliance partners etc.). Allows vendors autonomy in managing their assignments, while holding them accountable for deliverables. Ensures that tasks assigned to vendors are not duplicated by internal protocol/program team members.

Leverages scientific and clinical knowledge to contribute to responses to audit findings and Health Authority/Regulatory Agency requests. Exhibits clinical expertise to actively contribute to senior level scientific meetings. 

Builds strong relationships and encourages collaboration with team members and internal and external stakeholders across organizational, functional, and geographic boundaries to achieve project and/or program deliverables. Creates synergy with stakeholders and develops strong alliances with the Medical Monitor/Study Director, Operational Lead/Lead Protocol Manager, and other team members. Effectively leverages network of internal and external contacts.

Empowers team to achieve high performance and excellence. Holds self and others accountable for decisions and results achieved. Acts with integrity and models ethical behavior. Communicates in a concise and direct manner with transparency, confidentiality, clarity and honesty.

Creates an environment that encourages continuous improvement, innovation and appropriate risk taking in adherence with compliance standards.

Participates in the development of team members by helping them understand the correlation between clinical aspects and operational aspects of the Protocol. Provides Protocol specific guidance and training to the team.

Discusses scientific and disease-specific topics with credibility when interacting with sites, investigators, and other external and internal stakeholders. 

Effectively drives or contributes to non-project taskforces, business work streams, and initiatives. Promotes sharing of best practices and lessons learned.